The Effect of Mouth Closure on Airflow in OSA

Not Applicable

Completed

• Conditions: Hypopnea, Sleep
• Interventions: Other: Mouth closure

• Registration Number: NCT06547658
• Lead Sponsor: Brigham and Women's Hospital

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, we 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.

We evaluated the overall effect mouth closure on inspiratory airflow, and the change in inspiratory airflow with mouth closure across three mouth-breathing quantiles. We also evaluated if velopharyngeal obstruction was associated with mouth breathing and a negative airflow response to mouth closure.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-17
• Primary Completion: 2022-07-10
• Study Completion: 2022-07-10
• Status Verified: 2024-08
• Study First Submitted: 2024-08-01
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mouth closed	Mouth closure	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.

Primary Outcome Measures

Name	Time	Method
Total inspiratory flow	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).

Secondary Outcome Measures

Name	Time	Method
Change in total inspiratory airflow with mouth closure	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.	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.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States