Sleep Disordered BreathingPhase 2NCT03105297
To Characterize the Performance of the Nasal Dilator Strip in Lowering Nasal Resistance During Sleep, Promoting Nasal Route Breathing and Reducing the Signs and Symptoms of Sleep Disordered Breathing in a Group of Chronic Nocturnal Nasal Congestion Sufferers Who Report Trouble With Their Sleep.
A Phase 2 study testing Prototype nasal dilator strip and No strip in people with Sleep Disordered Breathing and Congestion, Nasal, run by GlaxoSmithKline at 1 site in Australia.
Trial summary
To characterize the performance of the nasal dilator strip in lowering nasal resistance during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep disordered breathing in a group of chronic nocturnal nasal congestion sufferers who report trouble with their sleep. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disordered Breathing, Congestion, Nasal
- What is being tested?
- Prototype nasal dilator strip and No strip
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Sep 2009to 10 Aug 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nostril types I and II (Inter-axial angle below 41 degrees = type I; inter-axial angle from 41 to 70 degrees = type II)
- Nasal Congestion: Have chronic nocturnal nasal congestion ('always or almost always') for at least the last year.
- Sleep: Reports trouble with sleep
Who cannot join
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to latex. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds), allergy or atopic reaction to adhesive bandages or latex.
- Subject has a chronic skin condition or eczema on the face or nose.
- Subject has visible open sores, sunburn, irritation on the face or nose immediately prior to treatment.
- Subject has severe obstructive sleep apnea/hypopnea syndrome with an AHI score <30 events/hour at the Baseline visit.
- Subject has had a diagnosis of another major sleep disorder (i.e. primary insomnia, i.e. regularly sleeping less than 6 hours per night, sleep insufficiency, i.e. sleeping >2 hours more on non-work days as compared to work days, narcolepsy, or periodic limb movement disorder).
- Subject has a non-typical sleep schedule (e.g. shift-work).
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- Subject plans travel involving time-zone changes during the study period.
- Subject takes medication known to have a significant effect on sleep. Use of any substance with psychotropic effects or properties known to affect sleep/wake, including but not limited to: neuroleptics, morphine/opioid derivatives, sedative antihistamines, stimulants, antidepressants, clonidine, barbiturates, anxiolytics, thalidomide, hypnotics and sedatives. Use of over the counter sleep promoting agents including diphenhydramine, doxylamine, tryptophan, valerian root, kava kava, melatonin, St John's Wort and Alluna. Use of over the counter alertness aids including caffeine and guarana.
- Subject currently uses any topical nasal decongestants (nasal sprays, drops, etc). Subject must have discontinued use of topical decongestants at least 7 days prior Baseline.
- Subject is experiencing an acute upper respiratory tract infection at during qualification phase and at Baseline visit.
- Subject abuses alcohol (regularly drinks more than 3 drinks per day) or has a recent history (within last 2 years) of substance or alcohol abuse. Regular consumption of xanthine-containing beverages (i.e. tea, coffee, or cola) comprising usually more than 5 cups or glasses per day.
- Subject has a positive drug of abuse screening result.
- Subject has severe, unstable disease states (e.g. myocardial infarction, congestive heart failure, diabetes, cirrhosis, cancer, epilepsy, or stroke), pain syndromes, (e.g. fibromyalgia) or any medical or surgical condition that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study or who in the judgement of the principal investigator would not be suitable for entry into this study.
- Severe nasal obstruction caused by structural abnormality that renders the subject unsuitable for the study in the opinion of the investigator, i.e. nasal polyps, severe deviated septum.
- Subject is unwilling to be videotaped or recorded during the PSG studies.
- Current Treatment for Sleep Disordered Breathing a) Subject currently uses devices prescribed for sleep disordered breathing including Continuous Positive Airway Pressure (CPAP), mandibular advancement devices, tongue displacement devices. b)Over-the-counter products such as chin straps, pillows, internal/external nasal dilators are acceptable provided usage is discontinued at least 28 days prior to Baseline.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Study of a Nasal Dilator Strip
To characterize the performance of the nasal dilator strip in lowering nasal resistance during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep disordered breathing in a group of chronic nocturnal nasal congestion sufferers who report trouble with their sleep.
Read the detailed description
This study was a baseline-controlled study. This study consisted of three phases: Baseline phase, 28 days Active phase (1 month in home treatment usage period with sleep laboratory nights after 7 (Night 8) and 28 days (Night 29) of treatment) followed by a two-night cross-over Nasal resistance phase. Screened participants were evaluated for sleep disordered breathing and PSG variables with sleep laboratory nights at Baseline, after 7 and 28 days of in house use of nasal dilator strip (Night 8 and 29 of Active phase), and at Day 30 and 31 (Night 30 and 31 of Nasal resistance phase). Participants wore the Nasal dilator strip during Active phase. Participants then entered the Nasal resistance phase of the study, which consisted of two sleep laboratory nights at Day 30 and 31 (Night 30 and 31) where they were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip" as per there randomization schedule.
- Conditions
- Sleep Disordered Breathing, Congestion, Nasal
- Being tested
- Prototype nasal dilator strip, No strip
- Keywords
- Nasal dilator strip, Sleep disordered breathing
- Medical subject headings
- Sleep Apnea Syndromes, Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prototype nasal dilator stripDevice
External Prototype Nasal Dilator strip. GSK prototype nasal dilator AB 2R11. All the participants used nasal dilator strip throughout the active phase of the study (Day 1 to Day 28). Followed by that all the participants used the nasal strip on Day 29 or 30 in Nasal resistance phase of the study as per their randomization sequence.
No stripOther
| Study group | Role | What they receive |
|---|---|---|
| All participants (Baseline phase) | Experimental | All the participants were applied nasal dilator strip during the sleep laboratory night on Day 1. Receives: Device: Prototype nasal dilator strip |
| All Participants (Active Phase) | Experimental | All the participants wore nasal dilator strip over a 1 month in-home use period and returned for sleep laboratory nights after 7 (Day 8) and 28 days (Day 29) of treatment Receives: Device: Prototype nasal dilator strip |
| All Participants (Nasal Resistance Phase) | Experimental | The participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule Receives: Device: Prototype nasal dilator strip; Other: No strip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nasal Resistance in Sleeping State : Nasal Resistance Phase
Nasal resistance of the participants with and without strip was measured in sleeping state using a nasal mask and a flow meter to obtain a trans-nasal pressure difference and nasal flow by continuous recording over the 2 nights [on Day 30 (Visit 5) and Day 31 (Visit 6), cumulatively], of the nasal resistance phase.
Measured: upto 2 days
Area at Minimum Cross Sectional Area 1 (MCA1) : Baseline Phase
Minimum cross sectional area 1 (MCA1) in the first 3 cm of the nasal cavity behind the nostril (0-3 cm), considered to be the area of the nasal valve and the distance from the nares of this restriction. MCA 1 was measured with an Acoustic Rhinometer at Day 1 (baseline phase) before and after Nasal dilator strip application.
Measured: Day 1
Volume at Minimum Cross-sectional Area 1 (MCA1) : Baseline Phase
Volume of the first 3 cm of the nasal cavity behind the nostril (0-3 cm2). Volume at MCA1 was measured with an Acoustic Rhinometer at Day 1 before and after Nasal dilator strip application.
Measured: Day 1
Nasal Resistance by Posterior Rhinomanometry : Baseline Phase
Nasal resistance was measured on Day 1, by a modified method of posterior rhinomanometry in awake and seated position. Using posterior rhinomanometry, the transnasal pressure difference was measured between the nasopharynx and the external nares. The technique measures the difference in transnasal pressure that drives the flow of air through the nasal cavities.
Measured: Day 1
Secondary outcomes (22)
Total Score of Composite Functional Outcomes of Sleep Questionnaire (FOSQ) : Active Phase
The FOSQ was 30-item, validated psychometric instrument that assessed the impact of disorders of excessive sleepiness on functional outcomes relevant to daily behaviors and quality of life (QoL). The responses to the questionnaire were grouped according to five factors for analysis: 1) Activity Level, 2) Vigilance, 3) Intimacy and Sexual Relationships, 4) General Productivity and 5) Social Outcome. Participant used a scale of 0 to 4 to score each question of FOSQ which then grouped in above factors (where 0= I don't do this activity for other reasons, 1= Yes, extreme difficulty, 2= Yes, moderate difficulty, 3= Yes, a little difficulty, and 4= No difficulty). Total score of composite FOSQ was the sum of scores obtained on all 30 questions of the questionnaire. The possible range for the total score of composite FOSQ was from 0-120. A higher total score of composite FOSQ indicates better QoL of the participant.
Measured: Day 29
Global Self Assessment Score : Active Phase
On Day 29, prior to sleep, participants were asked to rate their overall experience with the strip as compared to before they enrolled in the study: ease of breathing, staying asleep, falling back to sleep, waking up too early, number of awakenings, falling asleep, sleep quality, sleep depth, dry mouth upon awakening, morning headache, nocturia (waking up to urinate), feeling refreshed in the morning. Experience was rated on scale of -2 to 2 were: -2 = Much worse, -1 = Somewhat worse, 0 = No change, 1 = Somewhat improve, 2 = Much improved (higher score indicated improvement).
Measured: Day 29
Total Epworth Sleepiness Scale Score (ESS) : Active Phase
Participants answered the following question How likely are you to doze off or fall asleep in the following situations, in contrast to feeling just tired? 1. Sitting and reading, 2. Watching TV, 3. Sitting, inactive in a public place (e.g. a theatre or a meeting), 4. As a passenger in a car for an hour without a break, 5. Lying down to rest in the afternoon when circumstances permit, 6. Sitting and talking to someone, 7. Sitting quietly after a lunch without alcohol, and 8. In a car, while stopped for a few minutes in the traffic. Use the following scale to choose the most appropriate number for each situation: 0 = would never doze, 1 = slight chance of dozing, 2 = moderate chance of dozing, and 3 = high chance of dozing. Total ESS was calculated as the sum of all the individual scores observed for the above mentioned situations. The possible range for total ESS was 0-24. A lower total ESS indicates better sleep.
Measured: Day 29
Number of Snores Per Hour : Baseline, Active and Nasal Resistance Phase
The Investigator or designee recorded the number of snores per hour during the participant's domiciled sleep visits. Numbers of snores were recorded for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase
The Investigator or designee recorded the snoring percent (%) present in sleep time during the participant's domiciled sleep visits. Snoring % was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Average Snore Sound Intensity : Baseline, Active and Nasal Resistance Phase
The Investigator or designee recorded the average snore sound intensity during the participant's domiciled sleep visits. Average snore sound intensity was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Peak Sore Sound Intensity : Baseline, Active and Nasal Resistance Phase
The Investigator or designee recorded the peak snore sound intensity during the participant's domiciled sleep visits. Peak snore sound intensity was recorded for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Percentage of Participants With Nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
The Investigator or designee recorded the Nasal breathing route during the participant's domiciled sleep visits. Nasal breathing route was observed for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Percentage of Participants With Oro-nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
The Investigator or designee recorded the oro-nasal breathing route during the participant's domiciled sleep visits. Oro-nasal breathing route was observed for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Total Sleep Time (TST) : Baseline, Active and Nasal Resistance Phase
TST was measured by overnight polysomnography (PSG) using a computerized system. TST was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Sleep Efficiency (SE) : Baseline, Active and Nasal Resistance Phase
Sleep efficiency [SE, a polysomnography (PSG)] was measured as the percentage of total time in bed spent in sleep. It was calculated as the sum of Stage N1, Stage N2, Stage N3, and REM sleep, divided by the total time in bed and multiplied by 100. SE gives an overall sense of how well the participant slept and was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Sleep Onset Latency (SOL) : Baseline, Active and Nasal Resistance Phase
Sleep onset latency (SOL, a PSG parameter) was measured as the duration from the time when lights were turned off (as the participants attempted to sleep) till the time participant fell asleep. Determination of sleep and awake state was based on Electroencephalography (EEG) and behavioral parameters change. SOL was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Arousal Index (AI) : Baseline, Active and Nasal Resistance Phase
Arousal index (AI) is the number of arousals and awakenings, reported as a total number per hour of sleep. AI was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
Non-Rapid eye movement (NREM) sleep stage consist of 3 progressively deeper stages of sleep: N1 (transition period from being awake to falling asleep), N2 (where breathing and heart rate began to slow) and N3 (slow wave sleep where body heals and repair itself). Sleep architecture (SA) was measured by the percentage of sleep time spent by the participants in each stage (time spent in each stage to total time spent in NREM, multiplied by 100). SA was measured for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase
Total NREM (N1, 2, and 3) and REM sleep were calculated as the time spent by a participant in the NREM (measured during stable sleep) and REM sleep stages. Total NREM and REM sleep was measured by overnight PSG using a computerized system for all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Respiratory Effort Related Arousals (RERA) : Baseline, Active and Nasal Resistance Phase
Respiratory Effort Related Arousal (RERA) was flattening of an inspiratory portion of nasal pressure with increased respiratory effort leading to arousal. The total number of arousals per hour were calculated as RERA. RERA was measured all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase
Arterial oxygen saturation (SAO2) is the fraction of [oxygen]-saturated hemoglobin relative to total hemoglobin (unsaturated + saturated) in the blood. SAO2 in NREM and REM sleep was measured overnight by pulse oximetry with a finger probe using a computerized system. Lowest SAO2 values observed during the NREM and REM sleep were recorded for this endpoint. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Mean Arterial Oxygen Saturation (SAO2) During Sleep Time : Baseline, Active and Nasal Resistance Phase
SAO2 in sleep time was measured overnight by pulse oximetry with a finger probe using a computerized system. Mean of the observed SAO2 values during entire sleep time was reported for this endpoint. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Average Oxygen Desaturation During Sleep : Baseline, Active and Nasal Resistance Phase
Oxygen desaturation is the drop in blood's oxygen level per hours of sleep. Average drop in oxygen level during total sleep was measured overnight by pulse oximetry with a finger probe using a computerized system. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Greater Than 90% : Baseline, Active and Nasal Resistance Phase
Percent sleep time with SAO2 greater than 90% was measured overnight by pulse oximetry with a finger probe. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Less Than 90% : Baseline, Active and Nasal Resistance Phase
Percent sleep time with SAO2 less than 90% was measured overnight by pulse oximetry with a finger probe. Oximetry measurements were performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Apnea/Hypopnea Index (AHI) : Baseline, Active and Nasal Resistance Phase
Apnea/Hypopnea Index (AHI) was measured as the number of events (apnea and hypopnea) per hour of sleep. AHI was measured using overnight by PSG using a computerized system. PSG was performed in all participants with strip on Day 1 (Visit 2) in baseline phase, Day 8 (Visit 3) and Day 29 (Visit 4) in active phase, and in participants with and without strip on Day 30 (Visit 5) and Day 31 (Visit 6) cumulatively, in nasal resistance phase.
Measured: Day 1, Day 8, Day 29, Day 30 and Day 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start25 Sep 2009
- Primary completion10 Aug 2010
- Study completion10 Aug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Disordered BreathingStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study consisted of 3 phases baseline and active phase in which participants used the nasal dilator strip followed by 2 nights cross over nasal resistance phase in which participants were randomized to receive a sequence of strip/no strip or no strip/strip.
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105297
- Sponsor's protocol ID
- 202203
- Status last verified
- May 2019
- First submitted
- 5 Apr 2017
- Last updated
- 26 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wheatley JR, Amis TC, Lee SA, Ciesla R, Shanga G. Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion. Adv Ther. 2019 Jul;36(7):1657-1671. doi: 10.1007/s12325-019-00980-z. Epub 2019 May 22.
PubMed 31119695
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study of a Nasal Dilator Strip
- ClinicalTrials.gov ID
- NCT03105297
- Acronym / sponsor ID
- 202203
- Conditions
- Sleep Disordered Breathing, Congestion, Nasal
- Keywords
- Nasal dilator strip, Sleep disordered breathing
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Sep 2009 (actual)
- Primary completion
- 10 Aug 2010 (actual)
- Study completion
- 10 Aug 2010 (actual)
- First posted
- 7 Apr 2017 (actual)
- Results
- Posted 26 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To characterize the performance of the nasal dilator strip in lowering nasal resistance during sleep, promoting nasal route breathing and reducing the signs and symptoms of sleep disordered breathing in a group of chronic nocturnal nasal congestion sufferers who report trouble with their sleep.
Detailed description
This study was a baseline-controlled study. This study consisted of three phases: Baseline phase, 28 days Active phase (1 month in home treatment usage period with sleep laboratory nights after 7 (Night 8) and 28 days (Night 29) of treatment) followed by a two-night cross-over Nasal resistance phase. Screened participants were evaluated for sleep disordered breathing and PSG variables with sleep laboratory nights at Baseline, after 7 and 28 days of in house use of nasal dilator strip (Night 8 and 29 of Active phase), and at Day 30 and 31 (Night 30 and 31 of Nasal resistance phase). Participants wore the Nasal dilator strip during Active phase. Participants then entered the Nasal resistance phase of the study, which consisted of two sleep laboratory nights at Day 30 and 31 (Night 30 and 31) where they were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip" as per there randomization schedule.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This study consisted of 3 phases baseline and active phase in which participants used the nasal dilator strip followed by 2 nights cross over nasal resistance phase in which participants were randomized to receive a sequence of strip/no strip or no strip/strip.
| Arm | Type | Receives |
|---|---|---|
| All participants (Baseline phase) | Experimental | Device: Prototype nasal dilator stripAll the participants were applied nasal dilator strip during the sleep laboratory night on Day 1. |
| All Participants (Active Phase) | Experimental | Device: Prototype nasal dilator stripAll the participants wore nasal dilator strip over a 1 month in-home use period and returned for sleep laboratory nights after 7 (Day 8) and 28 days (Day 29) of treatment |
| All Participants (Nasal Resistance Phase) | Experimental | Device: Prototype nasal dilator strip, Other: No stripThe participants were randomized to receive a sequence of either 'strip'/' no strip' or 'no strip'/'strip' on 2 sleep laboratory nights (on Day 30 and Day 31) based on the randomization schedule |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Nostril types I and II (Inter-axial angle below 41 degrees = type I; inter-axial angle from 41 to 70 degrees = type II)
- Nasal Congestion: Have chronic nocturnal nasal congestion ('always or almost always') for at least the last year.
- Sleep: Reports trouble with sleep
Key exclusion criteria (16 listed)
- Allergy/Intolerance: Known or suspected intolerance or hypersensitivity to latex. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds), allergy or atopic reaction to adhesive bandages or latex.
- Subject has a chronic skin condition or eczema on the face or nose.
- Subject has visible open sores, sunburn, irritation on the face or nose immediately prior to treatment.
- Subject has severe obstructive sleep apnea/hypopnea syndrome with an AHI score <30 events/hour at the Baseline visit.
- Subject has had a diagnosis of another major sleep disorder (i.e. primary insomnia, i.e. regularly sleeping less than 6 hours per night, sleep insufficiency, i.e. sleeping >2 hours more on non-work days as compared to work days, narcolepsy, or periodic limb movement disorder).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prototype nasal dilator stripExternal Prototype Nasal Dilator strip. GSK prototype nasal dilator AB 2R11. All the participants used nasal dilator strip throughout the active phase of the study (Day 1 to Day 28). Followed by that all the participants used the nasal strip on Day 29 or 30 in Nasal resistance phase of the study as per their randomization sequence. | Device | All Participants (Active Phase), All Participants (Nasal Resistance Phase), All participants (Baseline phase) |
| No strip | Other | All Participants (Nasal Resistance Phase) |
Primary outcome
Nasal Resistance in Sleeping State : Nasal Resistance Phase
Time frame: upto 2 days
Nasal resistance of the participants with and without strip was measured in sleeping state using a nasal mask and a flow meter to obtain a trans-nasal pressure difference and nasal flow by continuous recording over the 2 nights [on Day 30 (Visit 5) and Day 31 (Visit 6), cumulatively], of the nasal resistance phase.
Area at Minimum Cross Sectional Area 1 (MCA1) : Baseline Phase
Time frame: Day 1
Minimum cross sectional area 1 (MCA1) in the first 3 cm of the nasal cavity behind the nostril (0-3 cm), considered to be the area of the nasal valve and the distance from the nares of this restriction. MCA 1 was measured with an Acoustic Rhinometer at Day 1 (baseline phase) before and after Nasal dilator strip application.
Volume at Minimum Cross-sectional Area 1 (MCA1) : Baseline Phase
Time frame: Day 1
Volume of the first 3 cm of the nasal cavity behind the nostril (0-3 cm2). Volume at MCA1 was measured with an Acoustic Rhinometer at Day 1 before and after Nasal dilator strip application.
Nasal Resistance by Posterior Rhinomanometry : Baseline Phase
Time frame: Day 1
Nasal resistance was measured on Day 1, by a modified method of posterior rhinomanometry in awake and seated position. Using posterior rhinomanometry, the transnasal pressure difference was measured between the nasopharynx and the external nares. The technique measures the difference in transnasal pressure that drives the flow of air through the nasal cavities.
22 secondary outcomes
Total Score of Composite Functional Outcomes of Sleep Questionnaire (FOSQ) : Active Phase
Time frame: Day 29
Global Self Assessment Score : Active Phase
Time frame: Day 29
Total Epworth Sleepiness Scale Score (ESS) : Active Phase
Time frame: Day 29
Number of Snores Per Hour : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Snoring Percent of Sleep Time : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Average Snore Sound Intensity : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Peak Sore Sound Intensity : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Percentage of Participants With Nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Percentage of Participants With Oro-nasal Breathing Route : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Total Sleep Time (TST) : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Sleep Efficiency (SE) : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Sleep Onset Latency (SOL) : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Arousal Index (AI) : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Sleep Architecture (Non-Rapid Eye Movement- Stages N1, N2 and N3) : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Total Non-rapid Eye Movement (NREM) and Rapid Eye Movement (REM) Sleep : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Respiratory Effort Related Arousals (RERA) : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Percentage of Lowest Arterial Oxygen Saturation (SAO2) During Rapid Eye Movement (REM) and Non-rapid Eye Movement (REM) Sleep Stage : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Mean Arterial Oxygen Saturation (SAO2) During Sleep Time : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Average Oxygen Desaturation During Sleep : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Greater Than 90% : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Percentage of Sleep Time With Arterial Oxygen Saturation (SAO2) Less Than 90% : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Apnea/Hypopnea Index (AHI) : Baseline, Active and Nasal Resistance Phase
Time frame: Day 1, Day 8, Day 29, Day 30 and Day 31
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31119695Wheatley JR, Amis TC, Lee SA, Ciesla R, Shanga G. Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion. Adv Ther. 2019 Jul;36(7):1657-1671. doi: 10.1007/s12325-019-00980-z. Epub 2019 May 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prototype nasal dilator strip and No strip in people with Sleep Disordered Breathing and Congestion, Nasal, run by GlaxoSmithKline at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nasal Resistance in Sleeping State : Nasal Resistance Phase (time frame: upto 2 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03105297, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.