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Completed

NCT Number: NCT06547658

The Effect of Mouth Closure on Airflow in OSA

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.

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Key information

Conditions

Hypopnea, Sleep Apnea Dyssomnias Mouth Breathing Nervous System Diseases Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mouth closure

Other

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

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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.

    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.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Massachusetts Eye and Ear Infirmary
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 9, 2024
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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