Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B

NCT ID: NCT01738009

Last Updated: 2022-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-08
• Study Completion Date: 2016-10-31

Brief Summary

In obstructive sleep apnea (OSA), the upper airway recurrently closes during sleep. The mechanisms that lead to airway closure are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea. The cause of PEN is unknown. The investigators will test if lung volumes and low respiratory drive play a role in PEN.

Detailed Description

The mechanisms that lead to airway closure in OSA are not completely understood. Some studies have shown that there is progressive narrowing of the pharyngeal airway across breaths during expiration (Progressive Expiratory Narrowing, PEN) preceding an obstructive apnea.

The investigators will test if lung volumes and low respiratory drive play a role in PEN. To this end, the investigators will visualize the pharynx of sleep apnea patients during sleep using a thin endoscope during sleep while simultaneously measuring lung volumes, genioglossus electromyogram, and pharyngeal pressure during flow-limited breaths. Flow limitation will be induced by sustained reductions of continuous positive airway pressure (CPAP).

Conditions

Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Induction of flow limitation

Flow limitation will be induced by sustained reductions in continuous positive airway pressure during sleep

Group Type: EXPERIMENTAL

Induction of flow limitation

Intervention Type: OTHER

Interventions

Induction of flow limitation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Normal subjects or patients with OSA

Exclusion Criteria

• Any unstable cardiac condition (other than well controlled hypertension) or pulmonary problems.
• Any medication known to influence breathing, sleep/arousal or muscle physiology
• Concurrent sleep disorders (insomnia, narcolepsy, central sleep apnea or parasomnia)
• Claustrophobia
• Inability to sleep supine
• Allergy to lidocaine or oxymetazoline hydroclhoride
• For women: Pregnancy

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David A Wellman, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1R01HL102321-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2012P000957B

Identifier Type: -

Identifier Source: org_study_id