Evaluation of muscle activity patterns in patients with severe obstructive sleep apnea

Not Applicable

Completed

• Conditions: Sleep apnoea, severe obstructive sleep apnea-hypopnea syndrome; Nervous System Diseases; Sleep apnoea

• Registration Number: ISRCTN12596010
• Lead Sponsor: Hospital Qironsalud Marbella

Brief Summary

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/34115605/ (added 14/06/2021) 2023 Results article in https://doi.org/10.1002/ohn.283 (added 27/02/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-24
• Study Completion: 2022-09-18
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

Current inclusion criteria as of 29/03/2021:
Cases:
1. Ages between 18 and 75 years
2. Diagnosis of moderate to severe OSAHS (AHI>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

Controls:
1. Adequate sleep hygiene
2. No complaints of snoring
3. No complaints of daytime sleepiness
4. Epworth Scale <7 points

Previous inclusion criteria:
Cases:
1. Ages between 18 and 75 years
2. Diagnosis of moderate to severe OSAHS (AHI>15) 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

Controls:
1. Adequate sleep hygiene
2. No complaints of snoring
3. No complaints of daytime sleepiness
4. Epworth Scale <7 points

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, CPAP)

Study & Design

• Study Type: Observational
• Study Design: Not specified