Dilator Muscle Activity in Health and Sleep Apnea

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: patients with OSA

• Registration Number: NCT04254341
• Lead Sponsor: Bnai Zion Medical Center

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.

Detailed 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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2020-02-02
• Study First Posted: 2020-02-05
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-13
• Last Update Posted: 2022-03-15
• Primary Completion: 2022-12
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with OSA	patients with OSA	Subjects that underwent regular sleep studies (PSG) and found to have moderate/severe obstructive sleep apnea
subjects without OSA	patients with OSA	Subjects that underwent regular PSG and found not to have sleep apnea

Primary Outcome Measures

Name	Time	Method
EMG activity of peri-pharyngeal muscles during wakefulness and sleep	4 hours	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%).