How muscle exercise affects the amount of fat in the tongue of patients with obstructive sleep apnea, using ultrasound to measure the changes

Influence of oropharyngeal exercises in genioglossus fat measured by ultrasound in sleep apnea patients

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN92645461

Enrollment

Registered

2023-03-09

Start date

2023-04-30

Completion date

Unknown

Last updated

2025-02-10

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

Conditions

Sleep apnea Nervous System Diseases

Interventions

Participants are randomised into groups using an online tool. 1. Control group. Patients with recent moderate-severe sleep apnea (1-3 months) undergoing treatment with postive pressure therapy (CPAP)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged between 18-75 years. 2. Diagnosis of moderate-severe OSA (iah>15). 3. Not having used any previous treatment other than that of the study or lasting longer than 3 months in the case of the control group. 4. Signature of informed consent (IC). 5. Present good permeability and nasal function. 6. BMI < 30 kg/m².

Exclusion criteria

Exclusion criteria: 1. Cognitive or neurological deficit. 2. Inability to complete questionnaires. 3. Severe alcoholism. 4. Presence of craniofacial malformations. 5. Active neoplastic disease. 6. History of previous rehabilitation treatment of the orofacial musculature as well as any other treatment for previous apnea that could modify the results of the study (Surgery, MAD). 7. Temporomandibular joint dysfunction 8. Ankyloglossia of the tongue or inability to perform MT exercises. 9. Not having a smartphone or inability to manipulate it, or internet network at home. 10. BMI >30 kg/m² 11. Weight changes with an increase of more than 5kg during the 3 months of study.

Design outcomes

Primary

Measure	Time frame
Tongue fat measured in millimeters by ultrasound pre and post-oropharyngeal exercises (baseline and 3 months)	—

Secondary

Measure	Time frame
Measured pre and post-oropharyngeal exercises (baseline and 3 months): 1. Drug induced sleep endoscopy findings measured using VOTE classification 2. Apnea hypopnea index (apneas per hour measured) using polysomnography 3. Minimal oxygen desaturation measured using polysomnography 4. Oxygen index desaturation measured using polysomnography 5. Tongue force and buccinator muscle, IOPI scores measured in kilopascals using IOPI Iowa oral performance instrument 6. Tongue force using digital spoon measured in grm/cm² 7. Sleepiness measured using Epworth sleepiness questionnaire 8. BMI Body mass index m/kg² 9. Neck circunference cm 10. Waist circumference cm	—

Measure

Time frame

Measured pre and post-oropharyngeal exercises (baseline and 3 months): 1. Drug induced sleep endoscopy findings measured using VOTE classification 2. Apnea hypopnea index (apneas per hour measured) using polysomnography 3. Minimal oxygen desaturation measured using polysomnography 4. Oxygen index desaturation measured using polysomnography 5. Tongue force and buccinator muscle, IOPI scores measured in kilopascals using IOPI Iowa oral performance instrument 6. Tongue force using digital spoon measured in grm/cm² 7. Sleepiness measured using Epworth sleepiness questionnaire 8. BMI Body mass index m/kg² 9. Neck circunference cm 10. Waist circumference cm

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Countries

Spain

Outcome results

None listed

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