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Electrical stimulation of the tongue in obstructive sleep apnea

Investigating the Effect of electrical stimulation of the tongue muscles on apnea improvement in patients with obstructive sleep apnea

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250423065454N1
Enrollment
33
Registered
2025-05-06
Start date
2025-06-22
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea (OSA) is a sleep disorder characterized by repeated episodes of partial or complete obstruction of the upper airway during sleep, leading to breathing pauses (apneas) or reduced airflow (hypopneas). This results in disrupted sleep, loud snoring, daytime fatigue, and potential health complications like high blood pressure, heart disease, or stroke if untreated. It is often associated with factors like obesity, anatomical airway issues, or relaxed throat muscles.. Obstruct

Interventions

Intervention group: patients with mild to moderate obstructive sleep apnea using electrical stimulation device under their tongue for 20 minutes daily before sleep for 6 weeks at home.

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age over 18 years Mild to moderate obstructive sleep apnea Unwillingness to use CPAP device or undergo surgery

Exclusion criteria

Exclusion criteria: BMI > 35 Symptomatic nasal pathology (e.g., deviated nasal septum, nasal polyps, or chronic rhinosinusitis) Tonsillar hypertrophy (tonsil size grade 3 or higher) Tongue or lip piercing Use of a pacemaker or implanted medical electrical devices Previous oral surgery for snoring Facial skeletal abnormalities related to the study (e.g., syndromic facial defects or severe micrognathia) Any oral disease/abnormal condition

Design outcomes

Primary

MeasureTime frame
Improving obstructive sleep apnea. Timepoint: Baseline: Before the intervention begins (prior to the 6-week treatment period).Post-intervention: Immediately after the completion of the 6-week treatment period. Method of measurement: Polysomnography (PSG): A comprehensive sleep study conducted to objectively measure Snore Index, Snore Time, AHI, and ODI. Questionnaires: Epworth Sleepiness Scale (ESS) , and Pittsburgh Sleep Quality Index (PSQI).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamed Amirifard

Tehran University of Medical Sciences

dr.amirifard@gmail.com+98 21 6119 0000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026