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Clinical Trials/NCT01738009
NCT01738009CompletedNot Applicable

Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B

Brigham and Women's Hospital1 site in 1 country40 target enrollmentStarted: December 8, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Difference in peak inspiratory flow

Study Overview

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 cause of PEN is unknown. The investigators will test if lung volumes and low respiratory drive play a role in PEN.

Detailed 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).

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
21 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Induction of flow limitation

Experimental

Flow limitation will be induced by sustained reductions in continuous positive airway pressure during sleep

Intervention: Induction of flow limitation (Other)

Outcomes

Primary Outcomes

Difference in peak inspiratory flow

Time Frame: 3 minutes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

David Andrew Wellman

Principal Investigator

Brigham and Women's Hospital

Study Sites (1)

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