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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-120
SponsorAGIR à Dom

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.).

Trial design

Design model

Parallel

Treatments tested in this trial

  • peer-driven intervention

    Behavioral

    Trained patient researchers will conduct 3 motivational sessions, according to the principle of motivational enhancement and cognitive-behavioral therapies, by videoconference meetings of 45 to 60 minutes duration with 5 to 8 patients within 6 months after each patient's inclusion.

Treatment groups

208 Participants
are divided into 2 treatment groups
Group A: Patient researcher interventionExperimental treatment 1 intervention
Group B: Usual careNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Evaluate the impact of a 6-month, peer-driven intervention to promote the resumption of CPAP after discontinuation

The range of patients reusing CPAP in the intervention group The difference in percentages of patients who reuse CPAP between the peer-driven intervention group and the control group.

Time frame
6 months after inclusion

Secondary outcomes

1

Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group

the difference in CPAP compliance (average hours of use/night) between the AP intervention group and a control group

Time frame
6 month after inclusion
2

Evaluate the impact of the peer-driven intervention on adherence to CPAP compared to the control group

the difference in percentages of patients who reuse to CPAP with at least 4 hours' use /night for 70% of nights

Time frame
6 month after inclusion
3

Disease-specific quality of life

The Functional Outcomes of Sleep Questionnaire (FOSQ10) will be completed at inclusion (M0) and at the 6-month follow-up (M6). This variable will be used to assess predictors of positive response to patient researcher intervention

Time frame
At inclusion and after 6 months
4

Patient Self-Efficacy Measure for Sleep Apnea

The Self-Efficacy Measure for Sleep Apnea (SEMSA) questionnaire, a tool with strong psychometric properties and with the potential for identifying patient perceptions will be completed at inclusion (M0) and at the 6-month follow-up (M6). This variable will be used to assess predictors of positive response to patient researcher intervention

Time frame
At inclusion and after 6 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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