Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D

Sleep Apnea Clinical Trial

Official title:

Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01733784
• Other study ID #: 2012P000957D
• Secondary ID: 1R01HL102321-01A
• Status: Withdrawn
• Phase: N/A
• Start date: December 8, 2012
• Est. completion date: February 7, 2017

Study information

• Verified date: July 2019
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 7, 2017
• Est. primary completion date: February 7, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Other:
• Induced central apneas

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper airway elasticity	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).	10 - 40 seconds