Hypopnea, SleepNCT06547658
The Effect of Mouth Closure on Airflow in OSA
A study testing Mouth closure in people with Hypopnea, Sleep, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Mouth breathing is associated with increased airway resistance, pharyngeal collapsibility, and obstructive sleep apnea (OSA) severity. It is commonly believed that closing the mouth can mitigate the negative effects of mouth breathing during sleep. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hypopnea, Sleep
- What is being tested?
- Mouth closure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2021to 10 Jul 2022
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed obstructive sleep apnea (AHI > 5 events/h).
- Scheduled to undergo clinical drug-induced sleep endoscopy.
Who cannot join
- pregnancy
- age under 18 years
- poor general health
- allergy to propofol or dexmedetomidine
- history of surgical treatment for sleep apnea, such as palate, tongue base, or epiglottis surgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: The Heterogeneous Effects of Mouth Closure on Airflow in Patients With Obstructive Sleep Apnea
Mouth breathing is associated with increased airway resistance, pharyngeal collapsibility, and obstructive sleep apnea (OSA) severity. It is commonly believed that closing the mouth can mitigate the negative effects of mouth breathing during sleep. However, the investigators propose that mouth breathing serves as an essential route bypassing obstruction along the nasal route (e.g., velopharynx). The present study investigates the role of mouth breathing as an essential route in some OSA patients and its association with upper airway anatomical factors.
Participants underwent drug-induced sleep endoscopy (DISE) with simultaneous pneumotach airflow measurements through the nose and mouth separately. During the DISE procedure, alternating mouth closure (every other breath) cycles were performed during flow-limited breathing.
The investigators evaluated the overall effect mouth closure on inspiratory airflow, and the change in inspiratory airflow with mouth closure across three mouth-breathing quantiles. The investigators also evaluated if velopharyngeal obstruction was associated with mouth breathing and a negative airflow response to mouth closure.
- Conditions
- Hypopnea, Sleep
- Being tested
- Mouth closure
- Keywords
- Obstructive sleep apnea, Mouth breathing, Upper airway, Drug-induced sleep endoscopy
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Apnea, Obstructive, Mouth Breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouth closureOther
Closing the mouth during sleep by applying pressure to the mentum until the teeth were in occlusion, without altering the head position.
| Study group | Role | What they receive |
|---|---|---|
| Mouth closed | Experimental | Closing the mouth by applying pressure to the mentum until the teeth were in occlusion, without altering the head position. Performed during flow-limited breathing. Receives: Other: Mouth closure |
| Mouth relaxed | No intervention | Mouth in the natural relaxed position during sleep. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total inspiratory flow
Change in airflow in the transition from mouth relaxed to mouth closed (intervention).
Measured: 1 day - the intervention of mouth closure on the outcome is applied acutely on alternating breaths, such that the effect of mouth closure is assessed based on the experiment which occurs in a single day.
Secondary outcomes (1)
Change in total inspiratory airflow with mouth closure
We analyzed the change in total inspiratory flow within three quantiles of roughly equal sample sizes based on oral breathing; quantile 1: oral airflow <0.05 L/min, quantile 2: oral airflow between 0.05 and 2.2 L/min, and quantile 3: oral airflow >2.2 L/min.
We also analyzed the effect of velopharyngeal obstruction on the change in total inspiratory airflow.
Measured: 1 day - the intervention of mouth closure is applied acutely on alternating breaths, such that the effect of mouth closure on the outcome is assessed based on the experiment which occurs in a single day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start17 Dec 2021
- Primary completion10 Jul 2022
- Study completion10 Jul 2022
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 Hypopnea, SleepStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Massachusetts Eye and Ear Infirmary, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, David Andrew Wellman, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547658
- Sponsor's protocol ID
- 2019P002847
- Other IDs
- R01HL128658
- Status last verified
- Jul 2026
- First submitted
- 1 Aug 2024
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to make the IPD available to other researchers.
Publications
Yang H, Huyett P, Wang TY, Sumner J, Azarbarzin A, Labarca GPT, Messineo L, Gell LK, Aishah A, Hu WH, White DP, Sands SA, Wellman A, Vena D. Mouth Closure and Airflow in Patients With Obstructive Sleep Apnea: A Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Nov 1;150(11):1012-1019. doi: 10.1001/jamaoto.2024.3319.
PubMed 39361293
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Heterogeneous Effects of Mouth Closure on Airflow in Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06547658
- Acronym / sponsor ID
- 2019P002847
- Conditions
- Hypopnea, Sleep
- Keywords
- Obstructive sleep apnea, Mouth breathing, Upper airway, Drug-induced sleep endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Massachusetts Eye and Ear Infirmary, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 Dec 2021 (actual)
- Primary completion
- 10 Jul 2022 (actual)
- Study completion
- 10 Jul 2022 (actual)
- First posted
- 9 Aug 2024 (actual)
- 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.
Mouth breathing is associated with increased airway resistance, pharyngeal collapsibility, and obstructive sleep apnea (OSA) severity. It is commonly believed that closing the mouth can mitigate the negative effects of mouth breathing during sleep. However, the investigators propose that mouth breathing serves as an essential route bypassing obstruction along the nasal route (e.g., velopharynx). The present study investigates the role of mouth breathing as an essential route in some OSA patients and its association with upper airway anatomical factors.
Participants underwent drug-induced sleep endoscopy (DISE) with simultaneous pneumotach airflow measurements through the nose and mouth separately. During the DISE procedure, alternating mouth closure (every other breath) cycles were performed during flow-limited breathing.
The investigators evaluated the overall effect mouth closure on inspiratory airflow, and the change in inspiratory airflow with mouth closure across three mouth-breathing quantiles. The investigators also evaluated if velopharyngeal obstruction was associated with mouth breathing and a negative airflow response to mouth closure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mouth closed | Experimental | Other: Mouth closureClosing the mouth by applying pressure to the mentum until the teeth were in occlusion, without altering the head position. Performed during flow-limited breathing. |
| Mouth relaxed | No intervention | –Mouth in the natural relaxed position during sleep. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed obstructive sleep apnea (AHI > 5 events/h).
- Scheduled to undergo clinical drug-induced sleep endoscopy.
Key exclusion criteria (5 listed)
- pregnancy
- age under 18 years
- poor general health
- allergy to propofol or dexmedetomidine
- history of surgical treatment for sleep apnea, such as palate, tongue base, or epiglottis surgery.
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 |
|---|---|---|
| Mouth closureClosing the mouth during sleep by applying pressure to the mentum until the teeth were in occlusion, without altering the head position. | Other | Mouth closed |
Primary outcome
Total inspiratory flow
Time frame: 1 day - the intervention of mouth closure on the outcome is applied acutely on alternating breaths, such that the effect of mouth closure is assessed based on the experiment which occurs in a single day.
Change in airflow in the transition from mouth relaxed to mouth closed (intervention).
1 secondary outcome
Change in total inspiratory airflow with mouth closure
Time frame: 1 day - the intervention of mouth closure is applied acutely on alternating breaths, such that the effect of mouth closure on the outcome is assessed based on the experiment which occurs in a single day.
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 10 Jul 2026.
- Derived from this study: PubMed 39361293Yang H, Huyett P, Wang TY, Sumner J, Azarbarzin A, Labarca GPT, Messineo L, Gell LK, Aishah A, Hu WH, White DP, Sands SA, Wellman A, Vena D. Mouth Closure and Airflow in Patients With Obstructive Sleep Apnea: A Nonrandomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2024 Nov 1;150(11):1012-1019. doi: 10.1001/jamaoto.2024.3319.
- Individual participant dataSharing planned: No. We do not plan to make the IPD available to other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouth closure in people with Hypopnea, Sleep, run by Brigham and Women's Hospital at 1 site 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 2 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 10 Jul 2026. 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 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?
Total inspiratory flow (time frame: 1 day - the intervention of mouth closure on the outcome is applied acutely on alternating breaths, such that the effect of mouth closure is assessed based on the experiment which occurs in a single day.). 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 NCT06547658, 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 10 Jul 2026.