Effect of hypnosis on adherence to continuous positive airway pressure.
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'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)
Critères d'exclusion
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)
Lieu de l’étude
Lausanne
(BASEC)
Sponsor
CHUV : Prof. Raphaël Heinzer directeur du CIRS au CHUV
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Solelhac Geoffroy
+41 21 314 67 48
geoffroy.solelhac@clutterchuv.chCHUV
(BASEC)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique du Vaud
(BASEC)
Date d'approbation du comité d'éthique
11.10.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT06397365 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Effect of hypnosis on adherence to continuous positive airway pressure therapy in sleep-disordered breathing: a randomized controlled trial (BASEC)
Titre académique
Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure Therapy in Sleep-disordered Breathing: a Randomized Controlled Trial (ICTRP)
Titre public
Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure. (ICTRP)
Maladie en cours d'investigation
Apnea SyndromeApnea, Obstructive (ICTRP)
Intervention étudiée
Other: medical hypnosis (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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)
non disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Geoffroy Solelhac, MD, geoffroy.solelhac@chuv.ch, +41213146748 (ICTRP)
ID secondaires
CHUVaudois-HypnOSA (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06397365 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible