NCT04254341

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

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Status
unknown

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

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2015

Completed
4.4 years until next milestone

First Posted

Study publicly available on registry

February 5, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

7.3 years

First QC Date

September 2, 2015

Last Update Submit

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

Other: patients with OSA

subjects without OSA

Subjects that underwent regular PSG and found not to have sleep apnea

Other: patients with OSA

Interventions

Sleep study

patients with OSAsubjects without OSA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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: 25814639BACKGROUND
  • Dotan 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

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Arie Oliven, MD

    Bnai Zion

    PRINCIPAL INVESTIGATOR

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