SnoringSNORENCT01949584
Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring
A study testing nasal continuous positive airway pressure less than or equal to 6 cm H2O in people with Snoring, run by inSleep Technologies, LLC at 3 sites in United States.
Trial summary
This is a prospective, interventional, study in which patients with a history of habitual snoring to determine whether low pressure nasal continuous airway pressure can reduce the frequency, duration or intensity of snoring in subjects with mild to moderate snoring who do not have Obstructive Sleep Apnea (OSA). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Snoring
- What is being tested?
- nasal continuous positive airway pressure less than or equal to 6 cm H2O
- Type of treatment
- Medical device
- How many people
- 26 participants
- Where
- 3 sitesUnited States
- Study dates
- Aug 2013to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is > 18 years of age.
- Subject is willing and able to provide written Informed Consent using a Patient Information and Consent form that has been reviewed and approved by a governing Institutional Review Board (IRB).
- Subject has a history of habitual snoring (almost every night or every night for at least 30% of the night) as determined by the subject or a bed-partner.
- Subject has been pre-screened and demonstrates no excess daytime sleepiness on an Epworth Questionnaire (an assessment of daytime sleepiness; high number = greater sleepiness) score of less than 11, no history of witnessed apneas or nocturnal gasping/choking episodes and a body mass index (BMI) ≤ 35.
- Subject meets Inclusion Criteria for the Baseline Trial (criteria a-d above)
- The subject has snoring intensity that exceeds 40 dBA during ≥30% of the respiratory efforts during sleep time on the baseline study night.
Who cannot join
- Subject has been diagnosed with COPD (Chronic Obstructive Pulmonary Disease), such as asthma, emphysema or chronic bronchitis.
- Subject has a history of heart disease, heart attack or stroke.
- Subject has uncontrolled or poorly controlled hypertension.
- Subject has been diagnosed with Obstructive Sleep Apnea (OSA), defined as an apnea hypopnea index (AHI) ≥ 5/hr in the presence of excessive sleepiness (an Epworth score ≥ 11) or AHI ≥15/hr when there is no evidence of excessive daytime sleepiness (an Epworth score ≤ 10).
- Subject is currently participating in another clinical study for which follow-up is ongoing.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
NeuroTrials Research, Inc.
Atlanta, Georgia, 30342
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
Doctors Community Hospital
Lanham, Maryland, 20706
About this study
This is a prospective, interventional, study in which patients with a history of habitual snoring to determine whether low pressure nasal continuous airway pressure can reduce the frequency, duration or intensity of snoring in subjects with mild to moderate snoring who do not have Obstructive Sleep Apnea (OSA).
Read the detailed description
In this a prospective, interventional, study, each patient will be studied four times. Subjects without OSA will undergo an initial observational control study to establish the presence of snoring (session 1); a single CPAP titration night to determine the minimally effective CPAP level (session 2) to alleviate snoring; a subsequent full night of CPAP treatment at this CPAP level (CPAP not to exceed 6 cm H2O) using the Cloud9™ low-pressure CPAP device (session 3); and a final control night of study conducted off CPAP to assess whether the patient's snoring remained stable over time (session 4). In this study, each subject shall serve as his/her own control.
- Conditions
- Snoring
- Being tested
- nasal continuous positive airway pressure less than or equal to 6 cm H2O
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal continuous positive airway pressure less than or equal to 6 cm H2ODevice
Also called Cloud9™ nasal CPAP device and nasal interface
Low level continuous positive airway pressure delivered during sleep.
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - The Cloud9™ device is expected to reduce the incidence of snoring.
The primary objective of this study is to demonstrate that minimally effective nasal CPAP (≤ 6 cm H2O) delivered by the Cloud9™ device reduces the number of snoring events and reduces snoring intensity in habitual, simple snorers in treatment session 3. We will test the hypothesis that the Cloud9™ device will decrease the number of loud snores by 50% or decrease the overall number of snores by 50%.
Measured: single night of sleep
Secondary outcomes (1)
Safety - Adverse events associated with CPAP (nasal or skin irritation, epistaxis and sleep disruption) will occur in few subjects.
Safety- Adverse events associated with the Cloud9™ device (nasal or skin irritation, epistaxis and sleep disruption) will occur in fewer than 20% of the subjects in this study.
Measured: two different single nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SnoringStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- inSleep Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University, Doctors Community Hospital, NeuroTrials Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Michael Lauk, Study director, inSleep Tech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01949584
- Sponsor's protocol ID
- IS103-PRO-00002
- Acronym
- SNORE
- Status last verified
- Mar 2015
- First submitted
- 20 Sep 2013
- Last updated
- 24 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guzman MA, Sgambati FP, Pho H, Arias RS, Hawks EM, Wolfe EM, Otvos T, Rosenberg R, Dakheel R, Schneider H, Kirkness JP, Smith PL, Schwartz AR. The Efficacy of Low-Level Continuous Positive Airway Pressure for the Treatment of Snoring. J Clin Sleep Med. 2017 May 15;13(5):703-711. doi: 10.5664/jcsm.6588.
PubMed 28356182
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Nasal Airflow Pressure Optimization to Resolve Excessive Snoring
- ClinicalTrials.gov ID
- NCT01949584
- Acronym / sponsor ID
- SNORE / IS103-PRO-00002
- Conditions
- Snoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- inSleep Technologies, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University, Doctors Community Hospital, NeuroTrials Research, Inc.
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, interventional, study in which patients with a history of habitual snoring to determine whether low pressure nasal continuous airway pressure can reduce the frequency, duration or intensity of snoring in subjects with mild to moderate snoring who do not have Obstructive Sleep Apnea (OSA).
Detailed description
In this a prospective, interventional, study, each patient will be studied four times. Subjects without OSA will undergo an initial observational control study to establish the presence of snoring (session 1); a single CPAP titration night to determine the minimally effective CPAP level (session 2) to alleviate snoring; a subsequent full night of CPAP treatment at this CPAP level (CPAP not to exceed 6 cm H2O) using the Cloud9™ low-pressure CPAP device (session 3); and a final control night of study conducted off CPAP to assess whether the patient's snoring remained stable over time (session 4). In this study, each subject shall serve as his/her own control.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subject is > 18 years of age.
- Subject is willing and able to provide written Informed Consent using a Patient Information and Consent form that has been reviewed and approved by a governing Institutional Review Board (IRB).
- Subject has a history of habitual snoring (almost every night or every night for at least 30% of the night) as determined by the subject or a bed-partner.
- Subject has been pre-screened and demonstrates no excess daytime sleepiness on an Epworth Questionnaire (an assessment of daytime sleepiness; high number = greater sleepiness) score of less than 11, no history of witnessed apneas or nocturnal gasping/choking episodes and a body mass index (BMI) ≤ 35.
- Subject meets Inclusion Criteria for the Baseline Trial (criteria a-d above)
Key exclusion criteria (5 listed)
- Subject has been diagnosed with COPD (Chronic Obstructive Pulmonary Disease), such as asthma, emphysema or chronic bronchitis.
- Subject has a history of heart disease, heart attack or stroke.
- Subject has uncontrolled or poorly controlled hypertension.
- Subject has been diagnosed with Obstructive Sleep Apnea (OSA), defined as an apnea hypopnea index (AHI) ≥ 5/hr in the presence of excessive sleepiness (an Epworth score ≥ 11) or AHI ≥15/hr when there is no evidence of excessive daytime sleepiness (an Epworth score ≤ 10).
- Subject is currently participating in another clinical study for which follow-up is ongoing.
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 |
|---|---|---|
| nasal continuous positive airway pressure less than or equal to 6 cm H2OAlso: Cloud9™ nasal CPAP device and nasal interfaceLow level continuous positive airway pressure delivered during sleep. | Device | – |
Primary outcome
Efficacy - The Cloud9™ device is expected to reduce the incidence of snoring.
Time frame: single night of sleep
The primary objective of this study is to demonstrate that minimally effective nasal CPAP (≤ 6 cm H2O) delivered by the Cloud9™ device reduces the number of snoring events and reduces snoring intensity in habitual, simple snorers in treatment session 3. We will test the hypothesis that the Cloud9™ device will decrease the number of loud snores by 50% or decrease the overall number of snores by 50%.
1 secondary outcome
Safety - Adverse events associated with CPAP (nasal or skin irritation, epistaxis and sleep disruption) will occur in few subjects.
Time frame: two different single nights
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2015.
- Derived from this study: PubMed 28356182Guzman MA, Sgambati FP, Pho H, Arias RS, Hawks EM, Wolfe EM, Otvos T, Rosenberg R, Dakheel R, Schneider H, Kirkness JP, Smith PL, Schwartz AR. The Efficacy of Low-Level Continuous Positive Airway Pressure for the Treatment of Snoring. J Clin Sleep Med. 2017 May 15;13(5):703-711. doi: 10.5664/jcsm.6588.
Related trials for Snoring
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingObservational study
Prediction of Tongue Base Obstruction During Sleep
Obstructive Sleep Disordered Breathing
Active, not recruiting
The Impact of Technology in Obstructive Sleep Apnea Myofunctional Therapy
Obstructive Sleep Apnea (OSA), Snoring
Active, not recruiting
DISE: Phenotyping Obstruction Patterns
Obstructive Sleep Apnea
RecruitingPhase 1
Use of Passive Myofunctional Appliances for Snoring and Mild Obstructive Sleep Apnea
Sleep Apnea, Obstructive
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.
Michael Lauk study director
inSleep Tech
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal continuous positive airway pressure less than or equal to 6 cm H2O in people with Snoring, run by inSleep Technologies, LLC at 3 sites in United States.
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 6 inclusion and 5 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 24 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy - The Cloud9™ device is expected to reduce the incidence of snoring. (time frame: single night of sleep). 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 NCT01949584, 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 24 Mar 2015.