SnoringPhase 1NCT01849406
Effect of Nasal Steroids in Snoring Intensity
A Phase 1 study testing nasal spray Budesonide and Nasal spray Normal Saline in people with Snoring, run by Ioannis Koutsourelakis at 1 site in Greece.
Trial summary
It is anecdotally well known that patients snore more when their nose is blocked. However, the therapeutic effect of improving nasal airway patency on snoring indices remains a point of conjecture. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Snoring
- What is being tested?
- nasal spray Budesonide and Nasal spray Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteGreece
- Study dates
- Apr 2013to Sep 2013
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- every night snoring;
- no medication known to influence nasal resistance (e.g., antihistamines, vasoconstrictors, topical or systemic steroids);
- no smoking for the last 6 months;
- no upper or lower respiratory tract disease (e.g., upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy; and
- written informed consent from each patient.
Who cannot join
- duration of snoring less than 60 minutes during sleep study, and
- central apnoeas more than five percent of total apnoeas.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Critical Care Medicine, Evangelismos Hospital of Athens
Athens
About this study
Official title: A Randomized Crossover Trial of the Effect of Nasal Steroids in Snoring Intensity
It is anecdotally well known that patients snore more when their nose is blocked. However, the therapeutic effect of improving nasal airway patency on snoring indices remains a point of conjecture. Indeed, Braver et al examined the effect of a nasal vasoconstrictor and failed to show any improvement in the number of snores after its application, although apnoea-hypopnoea index (AHI)seemed to decrease. Furthermore, Hoffstein et al documented that dilation of the anterior nares in patients without nasal pathology has a relatively weak effect on snoring, and routine use of nasal dilating appliances was not recommended for the treatment of snoring. In contrast to the aforementioned studies, intranasal corticosteroids have been shown to improve sleepiness and reduce AHI in patients with obstructive sleep apnea (OSA) implying that there might be an equivalent result for the use of nasal steroids on snoring indices.
Additionally, the present authors have demonstrated a strong correlation between apnoea-hypopnoea index and oral/oro-nasal breathing epochs in patients with OSA and normal nasal resistance and that nasal surgery is effective only in OSA patients who preoperatively have decreased nasal breathing epochs.
Read more
It is plausible thus to suggest that snoring severity, in equivalence to OSA severity, might be associated to oral/oro-nasal breathing epochs and that improving nasal patency by nasal steroids might also increase nasal breathing epochs and lead to decreased snoring indices in patients who had decreased nasal breathing before the administration of nasal steroids.
Patients will be randomized in two groups: the patients of the first group will undergo a one week therapy of nasal budesonide, then two weeks of washout period, and thereafter one week of nasal normal saline. The patients of the second group will undergo a one week therapy of nasal normal saline, then two weeks of washout period, and thereafter one week of nasal budesonide. Before and after each treatment regimen patients will undergo an assessment, which will consist of anterior rhinomanometry and polysomnography with concomitant measurement of snoring indices and breathing route pattern.
The investigators hypothesize that the application for one week of nasal budesonide has a beneficial effect on snoring indices in patients who present before the application decreased proportion of nasal breathing epochs and in whom nasal budesonide succeeded in increasing nasal breathing epochs.
Read the detailed description
Snoring intensity would be measured using a calibrated microphone-sound meter system. The 2 microphones will be suspended at a distance of 1 m approximately above the surface of the patient's bed. This arrangement allows a non-invasive measurement of snoring that simulates the distance between sleeping bed partners. Before every study the system would be acoustically calibrated using a reference noise produced by a noise generator (86 dB). The signal would be sent at a sampling rate of 12 KHz through an analogue-digital converter to a computer system for subsequent analysis. All digitized signals will be recorded in the hard disk of a personal computer. A noise analyzer (Praat; Boersma 2005) will be used for the intensity analysis of snoring sound (Boersma, 2005).
- Conditions
- Snoring
- Being tested
- nasal spray Budesonide, Nasal spray Normal Saline
- Medical subject headings
- Snoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal spray BudesonideDrug
Also called budesonide
one week therapy of nasal budesonide twice per day
Nasal spray Normal SalineDrug
Also called Normal saline
one week therapy of nasal normal saline twice per day
| Study group | Role | What they receive |
|---|---|---|
| Nasal spray Budesonide | Active comparator | one week therapy of nasal budesonide (twice per day) Receives: Drug: nasal spray Budesonide |
| Nasal spray Normal Saline | Placebo comparator | one week therapy of nasal normal saline (twice per day) Receives: Drug: Nasal spray Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
snoring intensity
Snoring intensity would be measured using a calibrated microphone-sound meter system
Measured: one week therapy
Secondary outcomes (1)
snoring frequency
Before and after each treatment regimen patients will undergo an assessment, which will consist of anterior rhinomanometry and polysomnography with concomitant measurement of snoring indices and breathing route pattern.
Measured: one week therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2013 (estimated)
- Study startApr 2013
- Primary completionSep 2013
- Study completionSep 2013
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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ioannis Koutsourelakis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ioannis Koutsourelakis, University of Athens
- Investigators
- Ioannis Koutsourelakis, MD, Principal investigator, University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01849406
- Sponsor's protocol ID
- NASTER
- Status last verified
- Sep 2013
- First submitted
- 14 Apr 2013
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pevernagie D, Aarts RM, De Meyer M. The acoustics of snoring. Sleep Med Rev. 2010 Apr;14(2):131-44. doi: 10.1016/j.smrv.2009.06.002. Epub 2009 Aug 8.
PubMed 19665907
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Crossover Trial of the Effect of Nasal Steroids in Snoring Intensity
- ClinicalTrials.gov ID
- NCT01849406
- Acronym / sponsor ID
- NASTER
- Conditions
- Snoring
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ioannis KoutsourelakisUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 May 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.
It is anecdotally well known that patients snore more when their nose is blocked. However, the therapeutic effect of improving nasal airway patency on snoring indices remains a point of conjecture. Indeed, Braver et al examined the effect of a nasal vasoconstrictor and failed to show any improvement in the number of snores after its application, although apnoea-hypopnoea index (AHI)seemed to decrease. Furthermore, Hoffstein et al documented that dilation of the anterior nares in patients without nasal pathology has a relatively weak effect on snoring, and routine use of nasal dilating appliances was not recommended for the treatment of snoring. In contrast to the aforementioned studies, intranasal corticosteroids have been shown to improve sleepiness and reduce AHI in patients with obstructive sleep apnea (OSA) implying that there might be an equivalent result for the use of nasal steroids on snoring indices.
Additionally, the present authors have demonstrated a strong correlation between apnoea-hypopnoea index and oral/oro-nasal breathing epochs in patients with OSA and normal nasal resistance and that nasal surgery is effective only in OSA patients who preoperatively have decreased nasal breathing epochs.
It is plausible thus to suggest that snoring severity, in equivalence to OSA severity, might be associated to oral/oro-nasal breathing epochs and that improving nasal patency by nasal steroids might also increase nasal breathing epochs and lead to decreased snoring indices in patients who had decreased nasal breathing before the administration of nasal steroids.
Patients will be randomized in two groups: the patients of the first group will undergo a one week therapy of nasal budesonide, then two weeks of washout period, and thereafter one week of nasal normal saline. The patients of the second group will undergo a one week therapy of nasal normal saline, then two weeks of washout period, and thereafter one week of nasal budesonide. Before and after each treatment regimen patients will undergo an assessment, which will consist of anterior rhinomanometry and polysomnography with concomitant measurement of snoring indices and breathing route pattern.
The investigators hypothesize that the application for one week of nasal budesonide has a beneficial effect on snoring indices in patients who present before the application decreased proportion of nasal breathing epochs and in whom nasal budesonide succeeded in increasing nasal breathing epochs.
Detailed description
Snoring intensity would be measured using a calibrated microphone-sound meter system. The 2 microphones will be suspended at a distance of 1 m approximately above the surface of the patient's bed. This arrangement allows a non-invasive measurement of snoring that simulates the distance between sleeping bed partners. Before every study the system would be acoustically calibrated using a reference noise produced by a noise generator (86 dB). The signal would be sent at a sampling rate of 12 KHz through an analogue-digital converter to a computer system for subsequent analysis. All digitized signals will be recorded in the hard disk of a personal computer. A noise analyzer (Praat; Boersma 2005) will be used for the intensity analysis of snoring sound (Boersma, 2005).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal spray Budesonide | Active comparator | Drug: nasal spray Budesonideone week therapy of nasal budesonide (twice per day) |
| Nasal spray Normal Saline | Placebo comparator | Drug: Nasal spray Normal Salineone week therapy of nasal normal saline (twice per day) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- every night snoring;
- no medication known to influence nasal resistance (e.g., antihistamines, vasoconstrictors, topical or systemic steroids);
- no smoking for the last 6 months;
- no upper or lower respiratory tract disease (e.g., upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy; and
- written informed consent from each patient.
Key exclusion criteria (2 listed)
- duration of snoring less than 60 minutes during sleep study, and
- central apnoeas more than five percent of total apnoeas.
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 spray BudesonideAlso: budesonideone week therapy of nasal budesonide twice per day | Drug | Nasal spray Budesonide |
| Nasal spray Normal SalineAlso: Normal salineone week therapy of nasal normal saline twice per day | Drug | Nasal spray Normal Saline |
Primary outcome
snoring intensity
Time frame: one week therapy
Snoring intensity would be measured using a calibrated microphone-sound meter system
1 secondary outcome
snoring frequency
Time frame: one week therapy
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 16 Sep 2013.
- Background: PubMed 19665907Pevernagie D, Aarts RM, De Meyer M. The acoustics of snoring. Sleep Med Rev. 2010 Apr;14(2):131-44. doi: 10.1016/j.smrv.2009.06.002. Epub 2009 Aug 8.
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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.
Ioannis Koutsourelakis, MD principal investigator
University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing nasal spray Budesonide and Nasal spray Normal Saline in people with Snoring, run by Ioannis Koutsourelakis at 1 site in Greece.
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 5 inclusion and 2 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 16 Sep 2013. 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 Greece. 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
snoring intensity (time frame: one week therapy). 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 NCT01849406, 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 16 Sep 2013.