Dilator Muscle Activity in Health and Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title:

Upper Airway Dilator Muscle Activity in Healthy Subjects and Patients With Obstructive Sleep Apnea During Wakefulness and Sleep

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04254341
• Other study ID #: 0096-14-BNZ
• Status: Enrolling by invitation
• Start date: September 2015
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Study plan: Subjects will be studied first during wakefulness, while breathing against external resistors, to evaluate how are the peri-pharyngeal muscles recruited and activated to prevent pharyngeal collapse in the presence of negative intra-pharyngeal pressures. Thereafter, the same parameters will be evaluated during sleep, to assess muscle recruitment during intra-pharyngeal obstruction. The investigaors will record the electromyogram (EMG) of several dilator muscles, as well as the pressures above and below the area of pharyngeal collapse, and airflow.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. subjects that underwent regular sleep studies and found to have either moderate/severe OSA, or no OSA. -

Exclusion Criteria:

1. hemophilia

2. use of anti-coagulants -

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• patients with OSA
Sleep study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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