Trained Patients as Research Partners in Sleep Apnea

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:

Trained Patients as Research Partners in Obstructive Sleep Apnoea Syndrome Who Stop CPAP: A Randomized Clinical Trial With Double Consent

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04774692
• Other study ID #: 2020-05
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: July 2023

Study information

• Verified date: February 2021
• Source: AGIR à Dom
• Contact: Christophe Pison, MD
• Phone: 04 76 76 54 53
• Email: CPison[@]chu-grenoble.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this randomized clinical trial is to evaluate the role of patient researchers in promoting the resumption of CPAP therapy in apneic patients who had previously stopped CPAP

Description:

Obstructive Sleep Apnoea syndrome (OSA) is one of the most frequent chronic disease presenting with or without symptoms of excessive daytime sleepiness (EDS) and being accompanied by neurocognitive, cardiovascular and metabolic complications.

The first line therapy of obstructive sleep apnoea is continuous positive airway pressure (CPAP). CPAP is highly effective in symptomatic patients for reducing EDS and improving daily functioning, cognitive function, mood and quality of life. However, success of CPAP treatment is hampered by long term nonadherence in nearly half of patients. Non adherence to CPAP is less and less related to technical problems, but rather to users' profile, their representations of OSA and the benefits experienced from CPAP. Cognitive-behavioural and motivation enhancement therapies can promote adherence to CPAP treatment. In addition to health professionals, patients and public involvement (PPI) is more and more advocated in the field of education and research. Nevertheless, the level of evidence regarding efficacy of PPI and patient researchers remains to be demonstrated. The aim of this randomized clinical trial is to evaluate the role of patient researchers in promoting the resumption of CPAP therapy in apneic patients who had previously stopped CPAP

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 206
• Est. completion date: July 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• OSA with AHI = 30 events/hour

• Failure to continue CPAP measured by home telemetry, 4 to 12 months after initiation with AGIR à dom. company

• Able to master oral and written French

• Able to provide written informed consent

Exclusion Criteria:

• Any unstable comorbidities that could influence the results

• Patient with heart failure

• Patient with central sleep apnoea index above 20% of AHI

• Vulnerable person or legally protected adult

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea Syndrome
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Syndrome

Intervention

Behavioral:
• Patient researcher intervention
Trained patient researchers will meet patients by phone, video-conference, and face to face meetings. They will conduct 3 motivational sessions according to the principle of motivational enhancement and cognitive-behavioral therapies (1-to build motivation for change, 2-to strengthen the commitment to change, 3-to reinforce change).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AGIR à Dom

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reuse of CPAP after 6 months (mean use of CPAP= 3 hours per night during 1 month)	The range of patients reusing CPAP in the intervention group	6 month after inclusion
Secondary	Reuse of CPAP after 6 months (mean use of CPAP= 4 hours per night, 70% of the nights during 1 month)	The range of patients reusing CPAP in the intervention group according to the US recommandations	6 month after inclusion
Secondary	Patient Quality of Life	Functional Outcomes of Sleep Questionnaire (FOSQ): a disease-specific quality of life questionnaire	At inclusion, after 3 months and after 6 months
Secondary	patient Self-Efficacy Measure	Self-Efficacy Measure for Sleep Apnea (SEMSA), a tool with strong psychometric properties and with the potential for identifying patient perceptions	At inclusion, after 3 months and after 6 months
Secondary	patient knowledge	Patient Activation Measure (PAM): a 22-item measure that assesses patient knowledge, skill, and confidence for self-management	At inclusion, after 3 months and after 6 months
Secondary	Acceptability and satisfaction	Acceptability and satisfaction of patient researcher intervention will be measured on a 5-point Likert scale: strongly agree, agree, neutral, disagree, and strongly disagree.	At 6 month after inclusion
Secondary	Age	This variable will be used to assess predictors of positive response to patient researcher intervention	At inclusion, after 3 months and after 6 months
Secondary	Gender	This variable will be used to assess predictors of positive response to patient researcher intervention	At inclusion, after 3 months and after 6 months
Secondary	Education level	This variable will be used to assess predictors of positive response to patient researcher intervention	At inclusion, after 3 months and after 6 months
Secondary	socio-professional Status	This variable will be used to assess predictors of positive response to patient researcher intervention	At inclusion, after 3 months and after 6 months
Secondary	Marital status	This variable will be used to assess predictors of positive response to patient researcher intervention	At inclusion, after 3 months and after 6 months
Secondary	Baseline Apnea-Hypopnea Index	This variable will be used to assess predictors of positive response to patient researcher intervention	At inclusion, after 3 months and after 6 months
Secondary	Excessive daytime sleepiness	Epworth sleepiness Scale will be used to assess predictors of positive response to patient researcher intervention	At inclusion, after 3 months and after 6 months
Secondary	Comorbidities	Charlson index will be used to assess predictors of positive response to patient researcher intervention	At inclusion, after 3 months and after 6 months