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Recruiting NCT07891702

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

Conditions: Obstructive Sleep Apnea

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Mansoura University

Location: Mansoura University Al Mansurah Dakahlia Governorate

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.

Eligibility Criteria

Inclusion Criteria: 1 - Adult patients aged 18 years or older. 2- Male or female patients diagnosed with obstructive sleep apnea by baseline overnight polysomnography. 3- Patients willing to participate in the study and provide written informed consent. Exclusion Criteria: 1. Patients with central sleep apnea or predominantly central sleep-disordered breathing. 2. Patients with significant unstable cardiovascular or respiratory disease that may increase the risk of participation. 3. Patients with implanted electronic devices, such as pacemakers or implantable cardioverter-defibrillators. 4. Patients with skin lesions, infection, irritation, or other abnormalities at the intended electrode application sites. 5. Patients with neurological or neuromuscular disorders that significantly affect upper airway muscle function. 6. Patients with a history of upper airway surgery that substantially alters upper airway anatomy, if this may interfere with study assessment. 7. Patients unable to tolerate electrical stimulation or complete the required polysomnography sessions. 8. Patients who decline to participate or withdraw their informed consent.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07891702). StuddyBuddy aggregates publicly available trial information.