Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D

NCT ID: NCT01733784

Last Updated: 2019-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-08

Study Completion Date

2017-02-07

Brief Summary

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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

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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.

Conditions

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Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Viscoelastic properties of the airway

Group Type EXPERIMENTAL

Induced central apneas

Intervention Type OTHER

Interventions

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Induced central apneas

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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David Andrew Wellman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David A Wellman, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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1R01HL102321-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2012P000957D

Identifier Type: -

Identifier Source: org_study_id

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