Dilator Muscle Activity in Health and Sleep Apnea
Upper Airway Dilator Muscle Activity in Healthy Subjects and Patients With Obstructive Sleep Apnea During Wakefulness and Sleep
1 other identifier
observational
20
0 countries
N/A
Brief Summary
The role of control of peri-pharyngeal muscle tone in the pathogenesis of obstructive sleep apnea (OSA) is obvious: pharyngeal obstruction occurs only during sleep; and pharyngeal collapse occurs in almost all healthy subjects during anesthesia. Better understanding of these control mechanisms may help identifying the central components of the pathogenesis of OSA.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Sep 2015
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 2, 2015
CompletedFirst Posted
Study publicly available on registry
February 5, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 15, 2022
March 1, 2022
7.3 years
September 2, 2015
March 13, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
EMG activity of peri-pharyngeal muscles during wakefulness and sleep
EMG of peripharyngeal muscles will be measured during wakefulness (on external resistors) and sleep (during flow limitation), patients with OSA. EMG data will be presented as %max (0-100%).
4 hours
Study Arms (2)
patients with OSA
Subjects that underwent regular sleep studies (PSG) and found to have moderate/severe obstructive sleep apnea
subjects without OSA
Subjects that underwent regular PSG and found not to have sleep apnea
Interventions
Eligibility Criteria
adult subjects with and without sleep apnea
You may qualify if:
- \. subjects that underwent regular sleep studies and found to have either moderate/severe OSA, or no OSA.
You may not qualify if:
- hemophilia
- use of anti-coagulants -
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Dotan Y, Pillar G, Schwartz AR, Oliven A. Asynchrony of lingual muscle recruitment during sleep in obstructive sleep apnea. J Appl Physiol (1985). 2015 Jun 15;118(12):1516-24. doi: 10.1152/japplphysiol.00937.2014. Epub 2015 Mar 26.
PMID: 25814639BACKGROUNDDotan Y, Pillar G, Tov N, Oliven R, Steinfeld U, Gaitini L, Odeh M, Schwartz AR, Oliven A. Dissociation of electromyogram and mechanical response in sleep apnoea during propofol anaesthesia. Eur Respir J. 2013 Jan;41(1):74-84. doi: 10.1183/09031936.00159611. Epub 2012 May 3.
PMID: 22556023BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arie Oliven, MD
Bnai Zion
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
September 2, 2015
First Posted
February 5, 2020
Study Start
September 1, 2015
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
March 15, 2022
Record last verified: 2022-03