Trained Patient Involvement to Promote the Resumption of CPAP in Patients Who Have Discontinued Its Use

AGIR à Dom

Status

Not yet enrolling

Conditions

Obstructive Sleep Apnea Syndrome

Treatments

Behavioral: peer-driven intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT04538274

2020-06

Details and patient eligibility

About

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

Full 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

Enrollment

208 estimated patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Over 18 years old
Diagnosed with of severe OSA (AHI ≥ 30 events/hour)
Discontinuation of CPAP 4 to 12 months after initiation Followed by the home health care provider Agiradom
Access to a computer and/or tablet and an internet connection
Oral and written French
Able to provide written informed consent
Affiliated to social security or beneficiary of such a scheme

Exclusion criteria

CPAP cessation due to a resolution of the OSAS (e.g. weight loss after bariatric surgery) or another pathology that prevents the continuation of treatment (e.g. ENT surgery, etc.).
Severe and/or unstable comorbidity that required hospitalisation for decompensation in the previous year (heart, kidney, respiratory, liver, psychiatric or other insufficiency).
Patient being treated with a mandibular advancement orthosis
Lack of availability (e.g. night worker or patient who travels frequently, etc.).
Current participation in, participation in the month prior to inclusion in another clinical intervention research study that may impact the study: this impact is left to the investigator's discretion.
Referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all protected persons: pregnant woman, breastfeeding mother, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure)