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

Not Applicable

Completed

• Conditions: Severe sleep apnea/hypopnea syndrome; Nervous System Diseases; Sleep apnoea

• Registration Number: ISRCTN90694424
• Lead Sponsor: Hospital Quironsalud Marbella

Brief Summary

2020 results in https://pubmed.ncbi.nlm.nih.gov/33093013/ (added 03/11/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-19
• Study Completion: 2020-10-01
• Last Update Posted: 16 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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