The Effect of Mouth Closure on Airflow in OSA

NCT ID: NCT06547658

Last Updated: 2024-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-17
• Study Completion Date: 2022-07-10

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mouth closed

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.

Group Type: EXPERIMENTAL

Mouth closure

Intervention Type: OTHER

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

Mouth relaxed

Mouth in the natural relaxed position during sleep.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mouth closure

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts Eye and Ear Infirmary

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

David Andrew Wellman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39361293 (View on PubMed)

Other Identifiers

R01HL128658

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2019P002847

Identifier Type: -

Identifier Source: org_study_id