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RECRUITING
NCT07891702
NA

Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea

Sponsor: Mansoura University

View on ClinicalTrials.gov

Summary

* The aim of this study is to assess the impact of transcutaneous electrical stimulation on polysomnographic findings in obstructive sleep apnea patients. * The hypothesis of the present study is that nocturnal delivery of transcutaneous electrical stimulation of the pharyngeal dilators, in particular the genioglossus, may help in treating the functional loss of the neuromuscular tone with sleep onset to keep the Upper airway patent during sleep which would reduce the severity of OSA as measured by the apnea-hypopnea-index (AHI), so representing an alternative and better-tolerated approach compared to usual care with CPAP.

Official title: Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea: A Prospective Interventional Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-07-06

Completion Date

2027-02

Last Updated

2026-10-23

Healthy Volunteers

No

Interventions

DEVICE

Transcutaneous Electrical Stimulation

Transcutaneous electrical stimulation will be delivered using an EV-906 Digital TENS/EMS device. Two 4 × 4 cm electrode patches will be placed bilaterally over the submental region, approximately halfway between the chin and the angle of the mandible. Stimulation will use a pulsed, symmetric, biphasic waveform at a frequency of 30 Hz and a phase duration of 200 microseconds, with 5-second ON and 5-second OFF cycles. Stimulation intensity will be titrated while the participant is awake to establish a tolerable sensory level. The intervention will be administered during the second overnight polysomnography session to assess its effects on polysomnographic parameters in patients with obstructive sleep apnea.

Locations (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt