Obstructive Sleep ApneaNCT07891702
Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea
A study testing Transcutaneous Electrical Stimulation in people with Obstructive Sleep Apnea, run by Mansoura University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Transcutaneous Electrical Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Jul 2025to Feb 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
Mohammed Shehta, dr_mshehta@mans.edu.eg
About this study
Official title: Effect of Transcutaneous Electrical Stimulation on Polysomnographic Parameters in Patients With Obstructive Sleep Apnea: A Prospective Interventional Study
- 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.
Read the detailed description
All participants will undergo a detailed clinical assessment, including:
- Medical history: Particular attention will be given to symptoms suggestive of OSA, including excessive daytime sleepiness, loud snoring, witnessed episodes of breathing cessation during sleep, fragmented sleep, and morning headaches. Daytime sleepiness will be assessed using the Epworth Sleepiness Scale.
- General and respiratory examination: General physical examination and chest examination will be performed, with particular attention to body mass index (BMI) and neck circumference.
- ENT examination: An ear, nose, and throat examination will be conducted to identify potential anatomical abnormalities that may contribute to upper airway obstruction.
- Baseline polysomnography: Full-night polysomnography will be performed to establish the diagnosis and characterize the severity of OSA.
- Intervention (Transcutaneous Electrical Stimulation):
- Transcutaneous electrical stimulation will be administered using a digital electrical muscle stimulator (EV-906 Digital TENS/EMS, Taiwan). Stimulation electrodes will be applied bilaterally to the submental region using two 4 × 4 cm electrode patches positioned approximately halfway between the chin and the angle of the mandible.
- Before the overnight intervention, stimulation intensity will be titrated while the participant is awake to establish a tolerable sensory level. Stimulation will initially be delivered at a frequency of 30 Hz for approximately one minute to assess comfort and determine the maximum tolerable current. The intensity will then be adjusted according to the participant's sensory response
- The stimulation waveform will be pulsed, biphasic, and symmetric, with the following parameters:
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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Transcutaneous Electrical Stimulation
- Keywords
- Obstructive sleep apnea, electrical stimulation, polysomnography, AHI,
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Electrical StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcutaneous Electrical Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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.
Measured: Baseline and within 1 week after baseline, during the second overnight polysomnography session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start6 Jul 2025
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, within-subject pre-post comparison
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Shehta, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07891702
- Sponsor's protocol ID
- MS.25.02.3087
- Status last verified
- Jul 2026
- First submitted
- 17 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21454399