The Effect of Mouth Closure on Airflow in OSA

NCT06547658 | Completed

• 2 other identifiers: 2019P002847R01HL128658
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypopnea, Sleep

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Total inspiratory flow

  Change in airflow in the transition from mouth relaxed to mouth closed (intervention).

  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

  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.

Study Arms (2)

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.

Other: Mouth closure

Mouth relaxed

NO INTERVENTION

Mouth in the natural relaxed position during sleep.

Interventions

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.

Mouth closed

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Massachusetts Eye and Ear Infirmary: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 39361293 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Mouth Breathing

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 1, 2024
• First Posted: August 9, 2024
• Study Start: December 17, 2021
• Primary Completion: July 10, 2022
• Study Completion: July 10, 2022
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)