NCT01733784

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 27, 2012

Completed
11 days until next milestone

Study Start

First participant enrolled

December 8, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2017

Completed
Last Updated

July 11, 2019

Status Verified

July 1, 2019

Enrollment Period

4.2 years

First QC Date

November 14, 2012

Last Update Submit

July 9, 2019

Conditions

Sleep Apnea

Keywords

Sleep ApneaPathophysiology

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Viscoelastic properties of the airway

EXPERIMENTAL
Other: Induced central apneas

Interventions

Induced central apneasOTHER
Viscoelastic properties of the airway

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Normal subjects or patients with OSA

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • David A Wellman, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 14, 2012

First Posted

November 27, 2012

Study Start

December 8, 2012

Primary Completion

February 7, 2017

Study Completion

February 7, 2017

Last Updated

July 11, 2019

Record last verified: 2019-07

Locations

US(1)