An interventional study of Transcutaneous Electrical Stimulation in Obstructive Sleep Apnea, sponsored by Mansoura University. Recruiting at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Mansoura University · Not applicable, Interventional, and Treatment
All participants will undergo a detailed clinical assessment, including:
Intervention (Transcutaneous Electrical Stimulation):
Frequency: 30 Hz. Phase duration (pulse width): 200 microseconds. Stimulation ON time: 5 seconds. Stimulation OFF time: 5 seconds. Electrode placement: Bilateral submental region.
The second full-night polysomnography session will be performed with active electrical stimulation. Stimulation delivery and monitoring will follow the study protocol, with participant comfort and safety taken into consideration.
Polysomnographic parameters recorded during the baseline and intervention sessions will be compared.
2,263 studies on the registry are indexed under Sleep Apnea, Obstructive; 465 are open to participants now.
This study's planned enrollment of 50 is close to the median of 53 across 1,490 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →Mansoura University is the lead sponsor of 1,114 studies on the registry; 185 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
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
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.
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.
Time frame: Baseline and within 1 week after baseline, during the second overnight polysomnography session with active electrical stimulation.
Change in Oxygen Desaturation Index (ODI)
The change in oxygen desaturation index (ODI), defined as the number of oxygen desaturation events per hour of sleep, between baseline polysomnography without electrical stimulation and polysomnography performed during active transcutaneous electrical stimulation.
Time frame: Baseline and within 1 week after baseline, during the second overnight polysomnography session.
Change in Sleep Efficiency
The change in sleep efficiency, calculated as total sleep time divided by total recording time in bed and expressed as a percentage, between baseline polysomnography and polysomnography performed during active transcutaneous electrical stimulation.
Time frame: Baseline and within 1 week after baseline, during the second overnight polysomnography session.
Plan to share: Undecided
Started Jul 2025 (actual). Primary completion is estimated for Jan 2027, 18 months after the start.
Of 511 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 53. This study's planned 18 months is below that.
Counting every sponsor, half of 621 studies reached it within 26 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.