Effect of hypnosis on adherence to continuous positive airway pressure.
Summary description of the study
Continuous positive airway pressure (CPAP) is the most effective treatment for respiratory disorders during sleep or obstructive sleep apnea syndrome. This treatment improves patients' functioning during the day (reduction of fatigue, daytime sleepiness, improvement of quality of life when these symptoms are present) and reduces cardiovascular risk (decrease in the risk of hypertension, for example). It has been shown in scientific studies that one of the important factors regarding the improvement of cardiovascular risk is the number of hours of CPAP treatment usage. The longer the usage duration, the less likely patients are to experience a stroke or heart attack. Adherence to CPAP treatment is therefore a public health issue. However, more than 30% of patients equipped with CPAP encounter difficulties in using the treatment despite the resolution of technical problems. Solutions to improve tolerance are often lacking. The use of medical hypnosis could help patients reduce the stress associated with the use of this treatment. Studies conducted so far have shown that medical hypnosis can improve certain sleep disorders.
(BASEC)
Intervention under investigation
In this study, we examine whether hypnosis can improve the average number of hours of nightly use of the CPAP machine compared to the usual follow-up without hypnosis.
(BASEC)
Disease under investigation
Obstructive sleep apnea syndrome treated with continuous positive airway pressure.
(BASEC)
≥ 18 years Indication for long-term treatment with continuous positive airway pressure for a respiratory disorder during sleep. Intolerance to CPAP with an average use of less than 3 hours/night (assessed during the second CPAP check by the healthcare provider 1 to 3 months after the introduction of CPAP). Ability to provide informed consent. (BASEC)
Exclusion criteria
Patient refusal to experiment with hypnosis. Patient refusing to use CPAP for more than 3 hours per night. Inability to communicate in French without a translator. Presence of a psychotic disorder. (BASEC)
Trial sites
Lausanne
(BASEC)
Sponsor
CHUV : Prof. Raphaël Heinzer directeur du CIRS au CHUV
(BASEC)
Contact
Contact Person Switzerland
Solelhac Geoffroy
+41 21 314 67 48
geoffroy.solelhac@clutterchuv.chCHUV
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
11.10.2024
(BASEC)
ICTRP Trial ID
NCT06397365 (ICTRP)
Official title (approved by ethics committee)
Effect of hypnosis on adherence to continuous positive airway pressure therapy in sleep-disordered breathing: a randomized controlled trial (BASEC)
Academic title
Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure Therapy in Sleep-disordered Breathing: a Randomized Controlled Trial (ICTRP)
Public title
Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure. (ICTRP)
Disease under investigation
Apnea SyndromeApnea, Obstructive (ICTRP)
Intervention under investigation
Other: medical hypnosis (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- = 18 years of age
- Indication for long-term CPAP treatment for sleep-disordered breathing.
- Intolerance of CPAP with use of less than 3h/night on average (assessed at the
second CPAP check-up by the home care provider 1 to 3 months CPAP introduction).
- Ability to provide informed consent.
Exclusion Criteria:
- Patient's refusal to experience hypnosis. (ICTRP)
not available
Primary and secondary end points
average hours of CPAP (ICTRP)
nights with CPAP use of more than 4 hours;patients continuing to use CPAP;sleepiness;sleep quality;Insomnia;Score at the Quebec Sleep Questionnaire;Anxiety and emotion (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
Geoffroy Solelhac, MD, geoffroy.solelhac@chuv.ch, +41213146748 (ICTRP)
Secondary trial IDs
CHUVaudois-HypnOSA (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06397365 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available