Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D

Not Applicable

Withdrawn

• Conditions: Sleep Apnea
• Interventions: Other: Induced central apneas

• Registration Number: NCT01733784
• Lead Sponsor: Brigham and Women's Hospital

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 investigators will assess the viscoelastic properties of the pharyngeal airway and its role in PEN.

Detailed Description

In obstructive sleep apnea, 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 investigators will test how the viscoelastic properties of the airway influence PEN. To this end, the investigators will visualize the pharynx of sleep apnea patients using a thin endoscope and will induce central apneas during sleep. Pharyngeal cross-sectional area will be recorded during incremental changes in pharyngeal pressure during central apneas.

Study Timeline

• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-27
• Study Start: 2012-12-08
• Primary Completion: 2017-02-07
• Study Completion: 2017-02-07
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-09
• Last Update Posted: 2019-07-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 hydrochloride
• For women: Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Viscoelastic properties of the airway	Induced central apneas	-

Primary Outcome Measures

Name	Time	Method
Upper airway elasticity	10 - 40 seconds	The investigators will determine elasticity of the upper airway during induced central apneas by dividing the change in airway pressure by the change in airway cross-sectional area.; The time frame for the outcome of this study is equal to the duration of the induced central sleep apnea (usually less than 40 seconds).

Trial Locations

Locations (1)

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