Obstructive Sleep Apnoea - OSA. Sleep apnea
Conditions
Interventions
Intervention 1: Intervention group: Participants in the intervention group will use a neuromuscular electrical stimulation (NMES) device for 20 minutes per day over a period of 4 weeks. The stimulatio
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: Inclusion CriteriaAdults aged =50 years.Diagnosed with moderate to severe obstructive sleep apnoea (AHI > 15 events/hour) based on polysomnography.BMI < 35 kg/m².Previous treatment with radiofrequency therapy for snoring or mild OSA.Willingness to provide written informed consent and comply with study procedures.
Exclusion criteria
Exclusion criteria: Exclusion CriteriaPresence of chronic obstructive pulmonary disease or other chronic respiratory diseases.Uncontrolled cardiovascular disease (e.g. NYHA Class III–IV heart failure).History of upper airway or maxillofacial skeletal anomalies.History of tonsil grade III hypertrophy or greater, or previous uvulopalatopharyngoplasty.Neuromuscular disorders affecting tongue or airway muscles.Known intolerance to CPAP therapy but with AHI < 5 under treatment.Use of implanted electronic medical devices (e.g. pacemaker).Pregnancy.Refusal or inability to participate or follow study protoco
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this study is the change in the Apnoea–Hypopnoea Index (AHI) and related sleep parameters after the use of a tongue stimulator device for 4 weeks.This includes improvement in respiratory disturbance events, oxygen desaturation parameters, snoring duration, and subjective sleepiness.The main hypothesis is that daily neuromuscular electrical stimulation of the tongue will reduce the severity of obstructive sleep apnoea and improve sleep quality. Timepoint: * Baseline (Week 0): Before starting the intervention (initial PSG and questionnaires).* Post-intervention (Week 4): After 4 weeks of daily tongue stimulator use (repeat PSG and questionnaires). Method of measurement: The Apnoea–Hypopnoea Index (AHI), mean oxygen saturation (SpO2), Oxygen Desaturation Index (ODI), and total snoring time will be measured by full-night attended polysomnography (PSG NO.4) using a sleep monitoring system.Subjective sleepiness and sleep quality will be assessed using validated questionnaires:* Epworth Sleepiness Scale (ESS)* Pittsburgh Sleep Quality Index (PSQI) All measurements will be performed by a sleep technician blinded to group allocation. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAbdolreza Bayat shahparast
Tehran University of Medical Sciences
Outcome results
None listed