Effect of hypnosis on adherence to continuous positive airway pressure.
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Lausanne
(BASEC)
Sponsor
CHUV : Prof. Raphaël Heinzer directeur du CIRS au CHUV
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Solelhac Geoffroy
+41 21 314 67 48
geoffroy.solelhac@clutterchuv.chCHUV
(BASEC)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Waadt
(BASEC)
Datum der Bewilligung durch die Ethikkommission
11.10.2024
(BASEC)
ICTRP Studien-ID
NCT06397365 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Effect of hypnosis on adherence to continuous positive airway pressure therapy in sleep-disordered breathing: a randomized controlled trial (BASEC)
Wissenschaftlicher Titel
Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure Therapy in Sleep-disordered Breathing: a Randomized Controlled Trial (ICTRP)
Öffentlicher Titel
Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure. (ICTRP)
Untersuchte Krankheit(en)
Apnea SyndromeApnea, Obstructive (ICTRP)
Untersuchte Intervention
Other: medical hypnosis (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Geoffroy Solelhac, MD, geoffroy.solelhac@chuv.ch, +41213146748 (ICTRP)
Sekundäre IDs
CHUVaudois-HypnOSA (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06397365 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar