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Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B

Mechanisms of Pharyngeal Collapse in Sleep Apnea, Study B

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01738009
Enrollment
40
Registered
2012-11-30
Start date
2012-12-08
Completion date
2016-10-31
Last updated
2022-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

Keywords

Sleep Apnea, Pathophysiology

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).

Interventions

OTHERInduction of flow limitation

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Difference in peak inspiratory flow3 minutesMeasured 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026