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NCT Number: NCT04538274

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

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 6 months after inclusion

    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.

Secondary outcomes

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

    Time frame: 6 month after inclusion

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

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

    Time frame: 6 month after inclusion

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

  3. Disease-specific quality of life

    Time frame: At inclusion and after 6 months

    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

  4. Patient Self-Efficacy Measure for Sleep Apnea

    Time frame: At inclusion and after 6 months

    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

  5. Patient knowledge, skill, and confidence for self-management

    Time frame: At inclusion and after 6 months

    The Patient Activation Measure (PAM) qestionnaire, a measure that assesses patient knowledge, skill, and confidence for self-management, 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

  6. Patient satisfaction and peer satisfaction

    Time frame: At 6 month after inclusion

    Patient satisfaction with the peer-driven intervention at 6 months will be measured on a 4-point Likert scale : very dissatisfied, dissatisfied, satisfied, very satisfied.

    Satisfaction of PI representatives will be measured on a 4-point Likert scale: very dissatisfied, dissatisfied, satisfied, very satisfied.

  7. Feasibility and the execution of the peer-driven intervention

    Time frame: At 6 month after inclusion

    Evaluate the feasibility and the execution of the peer-driven intervention

  8. Age

    Time frame: inclusion

    This variable will be used to assess predictors of positive response to patient researcher intervention

  9. Gender

    Time frame: inclusion

    This variable will be used to assess predictors of positive response to patient researcher intervention

  10. BMI Body Mass Index

    Time frame: inclusion

    This variable will be used to assess predictors of positive response to patient researcher intervention

  11. marital status with infants (<10 years) or not

    Time frame: inclusion

    This variable will be used to assess predictors of positive response to patient researcher intervention

  12. Education level

    Time frame: inclusion

    This variable will be used to assess predictors of positive response to patient researcher intervention

  13. employment and socio-professional status

    Time frame: inclusion

    This variable will be used to assess predictors of positive response to patient researcher intervention

  14. alcohol-smoking status

    Time frame: inclusion

    This variable will be used to assess predictors of positive response to patient researcher intervention

  15. fragility and social precariousness

    Time frame: inclusion

    EPICES score will be used to assess predictors of positive response to patient researcher intervention

  16. medication adherence

    Time frame: inclusion

    Girerd Score. This variable will be used to assess predictors of positive response to patient researcher intervention

  17. OSA history

    Time frame: inclusion

    date of diagnosis of OSA

  18. CPAP treatment

    Time frame: inclusion

    Date of initiation of CPAP and date and cause of CPAP discontinuation

  19. Baseline Apnea-Hypopnea Index (AHI)

    Time frame: inclusion

    This variable will be used to assess predictors of positive response to patient researcher intervention

  20. Excessive daytime sleepiness (EDS score)

    Time frame: inclusion

    Epworth Sleepiness Scale will be used to assess predictors of positive response to patient researcher intervention

  21. Comorbidities

    Time frame: inclusion

    Charlson index will be used to assess predictors of positive response to patient researcher intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Christophe Pison, MD

CONTACT

[email protected]

04 76 76 54 53 ext. +33

Raymon Merle

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

AGIR à Dom

Other

Registry information

Official study title

A Peer-driven Intervention to Help Patients Resume CPAP Therapy Following Discontinuation: a Multicenter, Randomized Clinical Trial with Patient Involvement

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 4, 2020
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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