Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D

• ClinicalTrials.gov Identifier: NCT01733784
• Recruitment Status: Withdrawn
• First Posted: November 27, 2012
• Last Update Posted: July 11, 2019
• Sponsor: Brigham and Women's Hospital
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): David Andrew Wellman, Brigham and Women's Hospital

Tracking Information

• First Submitted Date: November 14, 2012
• First Posted Date: November 27, 2012
• Last Update Posted Date: July 11, 2019
• Actual Study Start Date: December 8, 2012
• Actual Primary Completion Date: February 7, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 26, 2012)

Upper airway elasticity [ Time Frame: 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).

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D
• Official Title: Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study D
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Sleep Apnea
• Intervention: Other: Induced central apneas

Study Arms

Experimental: Viscoelastic properties of the airway

Intervention: Other: Induced central apneas

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: July 9, 2019): 0
• Original Estimated Enrollment (submitted: November 26, 2012): 40
• Actual Study Completion Date: February 7, 2017
• Actual Primary Completion Date: February 7, 2017 (Final data collection date for primary outcome measure)

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 hydrochloride
• For women: Pregnancy

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01733784
• Other Study ID Numbers: 2012P000957D; 1R01HL102321-01A1 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: David Andrew Wellman, Brigham and Women's Hospital
• Study Sponsor: Brigham and Women's Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

Investigators

• Principal Investigator: David A Wellman, MD; Brigham and Women's Hospital

• PRS Account: Brigham and Women's Hospital
• Verification Date: July 2019