Effect of throat exercises in lower jaw advancement to treat sleep apnea

Not Applicable

• Conditions: Sleep apnea; Nervous System Diseases; Sleep apnoea

• Registration Number: ISRCTN13128082
• Lead Sponsor: Quirons salud investigacion

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-17
• Last Update Posted: 1 May 2023
• Study Completion: 2025-05-03

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

1. Aged between 18 and 75 years
2. Diagnosis of moderate OSAHS (AHI between 15-30) without having had previous experience of said condition and not undergoing treatment due to different circumstances
3. Not having undergone any previous treatment for OSAHS
4. Signed informed consent (IC) form

Exclusion Criteria

1. Cognitive or neurological deficit
2. Inability to answer questionnaires
3. Severe alcoholism
4. Presence of craniofacial malformations
5. Active neoplastic disease
6. History of prior orofacial muscle rehabilitation therapy and any prior apnoea treatment which may modify the study results (surgery, MAD, continuous positive airway pressure [CPAP])
7. Not having a smartphone
8. Temporomandibular joint dysfunction
9. Absence of dentition to wear a MAD

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Apnea-hypopnea index (AHI) measured by polysomnography/polygraphy measured on the first day and after 3 months

Secondary Outcome Measures

Name	Time	Method
Measured on the first day and after 3 months (except for sleep diary):<br>1. Oxygen desaturation index (ODI) measured by polygraphy/polysomnography<br>2. Minimal O2 desaturation (min sat o2) measured by polygraphy/polysomnography<br>3. Strength of the genioglossus muscle measured by Tongue Digital Spoon (TDS) and Iowa Oral Performance Instrument (IOPI)<br>4. Adherence to the use of MAD measured by sleep diary daily <br>5. Sleepiness measured with the Epworth sleepiness scale subjective scale<br>6. Subjective measure of snoring by partner using Visual Analogue Scale (VAS)<br>7. Quality of sleep measured with Pittsburgh questionnaires<br>8. Oropharynx dimensions measured with Friedman anatomical scales