Effect of hypnosis on adherence to continuous positive airway pressure.
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Losanna
(BASEC)
Sponsor
CHUV : Prof. Raphaël Heinzer directeur du CIRS au CHUV
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Solelhac Geoffroy
+41 21 314 67 48
geoffroy.solelhac@clutterchuv.chCHUV
(BASEC)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica Vaud
(BASEC)
Data di approvazione del comitato etico
11.10.2024
(BASEC)
ID di studio ICTRP
NCT06397365 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Effect of hypnosis on adherence to continuous positive airway pressure therapy in sleep-disordered breathing: a randomized controlled trial (BASEC)
Titolo accademico
Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure Therapy in Sleep-disordered Breathing: a Randomized Controlled Trial (ICTRP)
Titolo pubblico
Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure. (ICTRP)
Malattie studiate
Apnea SyndromeApnea, Obstructive (ICTRP)
Intervento studiato
Other: medical hypnosis (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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 disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
non disponibile
Contatti aggiuntivi
Geoffroy Solelhac, MD, geoffroy.solelhac@chuv.ch, +41213146748 (ICTRP)
ID secondari
CHUVaudois-HypnOSA (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06397365 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile