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

Not Applicable

Conditions: Sleep apnea
Nervous System Diseases

Registration Number: ISRCTN92645461

Lead Sponsor: Hospital Quironsalud Marbella

Brief Summary: 2024 Protocol article in https://pubmed.ncbi.nlm.nih.gov/38398705/ (added 15/05/2024)

Detailed Description: Not available

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 45

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

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tongue fat measured in millimeters by ultrasound pre and post-oropharyngeal exercises (baseline and 3 months)

Secondary Outcome Measures

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