The effects of an m-health application for exercising the mouth and facial muscles in patients with sleep obstructive syndrome

Effects of myofunctional therapy with an m-health application airway gym in severe apnea/hypopnea sleep obstructive syndrome. A randomized multicentre control trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN90694424

Enrollment

Registered

2020-05-19

Start date

2019-02-01

Completion date

Unknown

Last updated

2020-11-16

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

Conditions

Severe sleep apnea/hypopnea syndrome Nervous System Diseases Sleep apnoea

Interventions

Experimental group: Myofunctional exercises based on a mHealth App AirwayGym daily performed during 3 months 20 minutes a day. Control group: No intervention. Patients

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age between 18-75 years 2. Recently diagnosed with severe sleep apnea and do not have any previous experience or information with this pathology 3. Consent signed

Exclusion criteria

Exclusion criteria: 1. IMC (BMI) >40 kg/m² 2. Inability to fill up questionnaires 3. Severe drug or alcohol abuse 4. Hypnotic medication 5. Not controlled coronary disease 6. Decompensated Heart failure 7. Stroke 8. Systemic Disease associated with inflammatory diagnosed entity (arthritis, sarcoidosis, vasculitis, lupus…) 9. Neuromuscular disease (like Duchenne) 10. Craniofacial deformities. 11. Active oncologic process. 12. Any antecedents of MT treatment or other treatment for sleep apnea could affect study results of the study (surgery, DAM or CPAP). Once the patient accepted and signed consent and met inclusion criteria, they will be attended by Ent specialist to rule out: 13. Severe upper airway obstruction (Complete nose obstruction, Tonsills grade IV/IV ) 14. Presence of tongue tie (Marchesani Protocole) with limitation of tongue movements 15. Antecedents or presence of temporomandibular joint disorders

Design outcomes

Primary

Measure	Time frame
At baseline and 3 months: 1. Severity of apnea measured using The Apnea–Hypopnea Index 2. Saturation O2 and Nadir O2 measured using oximeter 3. Tongue strength measured using the Iowa Oral Performance Instrument (IOPI)	—

Secondary

Measure	Time frame
Measured each month for 3 months: 1. Sleep quality measured using Pittsburgh Sleep Quality Index (PSQI) 2. Sleepiness measured using Epworth sleepiness scale 3. BMI (kg/m²) 4. Neck and waist circumference (cm)	—

Countries

Spain

Outcome results

None listed

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