Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B

Sleep Apnea Clinical Trial

Official title:

Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01738009
• Other study ID #: 2012P000957B
• Secondary ID: 1R01HL102321-01A
• Status: Completed
• Phase: N/A
• Start date: December 8, 2012
• Est. completion date: October 2016

Study information

• Verified date: February 2022
• 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 cause of PEN is unknown. The investigators will test if lung volumes and low respiratory drive play a role in PEN.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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 hydroclhoride

• For women: Pregnancy

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes

Intervention

Other:
• Induction of flow limitation

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	Difference in peak inspiratory flow	Measured peak inspiratory flow will be compared to predicted peak inspiratory flow during flow restricted breaths.; The time frame for the outcome will be the duration of induced flow limitation (3 minutes each) . Flow limitation will be induced several times during the night. Flow limited breaths will be averaged.	3 minutes