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The Effect of Mouth Closure on Airflow in OSA

The Heterogeneous Effects of Mouth Closure on Airflow in Patients With Obstructive Sleep Apnea

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06547658
Enrollment
66
Registered
2024-08-09
Start date
2021-12-17
Completion date
2022-07-10
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypopnea, Sleep

Keywords

Obstructive sleep apnea, Mouth breathing, Upper airway, Drug-induced sleep endoscopy

Brief 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. 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.

Interventions

OTHERMouth closure

Closing the mouth during sleep by applying pressure to the mentum until the teeth were in occlusion, without altering the head position.

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER
Massachusetts Eye and Ear Infirmary
CollaboratorOTHER
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No

Inclusion criteria

* Diagnosed obstructive sleep apnea (AHI \> 5 events/h). * Scheduled to undergo clinical drug-induced sleep endoscopy.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Total inspiratory flow1 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).

Secondary

MeasureTime frameDescription
Change in total inspiratory airflow with mouth closure1 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.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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026