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

NCT07891702 | Recruiting DMC

• 1 other identifier: MS.25.02.3087
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive sleep apnea, electrical stimulation, polysomnography, AHI,

Outcome Measures

Primary Outcomes (1)

• Change in Apnea-Hypopnea Index (AHI)

  The change in the apnea-hypopnea index (AHI), defined as the number of apneas and hypopneas per hour of sleep, between baseline overnight polysomnography performed without electrical stimulation and the second overnight polysomnography performed during active transcutaneous electrical stimulation. AHI will be compared between the two sessions to evaluate the acute effect of electrical stimulation on OSA severity.

  Baseline and within 1 week after baseline, during the second overnight polysomnography session with active electrical stimulation.

Secondary Outcomes (2)

• Change in Oxygen Desaturation Index (ODI)

  Baseline and within 1 week after baseline, during the second overnight polysomnography session.

• Change in Sleep Efficiency

  Baseline and within 1 week after baseline, during the second overnight polysomnography session.

Study Arms (1)

Transcutaneous Electrical Stimulation Group

EXPERIMENTAL

Participants diagnosed with obstructive sleep apnea will undergo baseline overnight polysomnography without electrical stimulation, followed within one week by a second overnight polysomnography session during active transcutaneous electrical stimulation of the submental region. Each participant will serve as their own control, and polysomnographic parameters will be compared between the two sessions.

Device: Transcutaneous Electrical Stimulation

Interventions

Transcutaneous Electrical Stimulation DEVICE

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.

Transcutaneous Electrical Stimulation Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 years or older. 2- Male or female patients diagnosed with obstructive sleep apnea by baseline overnight polysomnography.
• Patients willing to participate in the study and provide written informed consent.

You may not qualify if:

• Patients with central sleep apnea or predominantly central sleep-disordered breathing.
• Patients with significant unstable cardiovascular or respiratory disease that may increase the risk of participation.
• Patients with implanted electronic devices, such as pacemakers or implantable cardioverter-defibrillators.
• Patients with skin lesions, infection, irritation, or other abnormalities at the intended electrode application sites.
• Patients with neurological or neuromuscular disorders that significantly affect upper airway muscle function.
• Patients with a history of upper airway surgery that substantially alters upper airway anatomy, if this may interfere with study assessment.
• Patients unable to tolerate electrical stimulation or complete the required polysomnography sessions.
• Patients who decline to participate or withdraw their informed consent.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, Dakahlia Governorate, 35516, Egypt

RECRUITING

Related Publications (1)

• Steier J, Seymour J, Rafferty GF, Jolley CJ, Solomon E, Luo Y, Man WD, Polkey MI, Moxham J. Continuous transcutaneous submental electrical stimulation in obstructive sleep apnea: a feasibility study. Chest. 2011 Oct;140(4):998-1007. doi: 10.1378/chest.10-2614. Epub 2011 Mar 31.

  PMID: 21454399 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

Mohammed Shehta, Associate professor-chest med.

CONTACT

+201004344106; dr_mshehta@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Single-arm, within-subject pre-post comparison

Study Record Dates

• First Submitted: October 17, 2026
• First Posted: October 23, 2026
• Study Start: July 6, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: October 23, 2026

Record last verified: 2026-07

Locations

EG (1)