Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea

Not Applicable

Completed

• Conditions: Sleep Apnea, Obstructive

• Registration Number: NCT04691479
• Lead Sponsor: Air Liquide Healthcare Spain

Brief Summary

A multicentre, randomized controlled trial (RCT) design.The control group followed the usual treatment, while the intervention group (PIMA) followed the treatment with an adapted and flexible care plan depending on socio-demographic, clinical and psychological variables. The treatment plan includes different channels (home, telephone, care center), a continuous evaluation, and the use of the motivational interview in each of the interventions with the patient. The main outcome was adherence. Secondary outcomes were quality of life, emotional state, activities, social relationships, perceived competence and motivation.

Detailed Description

The aim of this trial was to determine adherence to CPAP and health- related outcomes in patients with OSA via a comprehensive and multidisciplinary program based on stratification and individualized care plans, including the motivational interview.

A multicentre, randomized controlled trial (RCT) design was used. The control group followed the usual treatment, while the intervention group (PIMA) followed the treatment with an adapted and flexible care plan depending on socio-demographic, clinical and psychological variables. The treatment plan includes different channels (home, telephone, care center), a continuous evaluation, and the use of the motivational interview in each of the interventions with the patient. The main outcome was adherence. Secondary outcomes were quality of life, emotional state, activities, social relationships, perceived competence and motivation.

Study Timeline

• Study Start: 2018-03-10
• Primary Completion: 2018-09-11
• Study Completion: 2018-11-20
• Status Verified: 2020-12
• Study First Submitted: 2020-12-21
• Study First Submitted QC: 2020-12-29
• Last Update Submitted: 2020-12-29
• Study First Posted: 2020-12-31
• Last Update Posted: 2020-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Older than 18 years
• Diagnosis of OSA confirmed by sleep studies with polygraphy (PS) and / or polysomnography (PSG)

Exclusion Criteria

• Subjects with obesity-related hypoventilation
• Severe COPD (chronic obstructive pulmonary disease)
• Cognitive disorders and those unable to understand the consent to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Somnolence (changes)	Day 1, Day 90, Day 180	Residual sleepiness after use of CPAP. Epworth Sleepiness Scale. Minimum score: 0; Maximum: 24. Higher scores=worse outcome
Perceived Competence (changes)	Day 1, Day 90, Day 180	Self-Efficacy in the CPAP treatment. Perceived Competence Evaluation Questionnaire. Minimum score: 0; Maximum score 13. Higher score= Better outcome.
Adherence (changes)	Day 90, Day 180	Number of hours of use of CPAP per night

Secondary Outcome Measures

Name	Time	Method
Quality of Life (Changes)	Day 1, Day 90, Day 180	Well-Being of the patient related to sleep apnea. Analogical Well-Being in Sleep Apnea Scale. Mininum score: 0; Maximum score: 10. Higher score= better outcome.
Mood (Changes)	Day 1, Day 90, Day 180	Emotional status related to sleep apnea. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.
Activities (Changes)	Day 1, Day 90, Day 180	Improving general activity after use CPAP. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.
Social Relations (Changes)	Day 1, Day 90, Day 180	Improving general social relations after use CPAP. Ad hoc question. Minimum score: 0; maximum score: 3. Higher score: Better outcome.

Trial Locations

Locations (1)

David Rudilla; 🇪🇸 Madrid, Spain