Clinical trial NCT06397365: Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure.
Official title: Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure Therapy in Sleep-disordered Breathing: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Apnea Syndrome
Apnea, Obstructive
Keywords: CPAP adherence
medical hypnosis
obstructive sleep apnea
Lead sponsor: Centre Hospitalier Universitaire Vaudois
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The prevalence of sleep-disordered breathing is high, with an apnea-hypopnea index of over 15 per hour found in 49.7% of men and 23.4% of women in the general population (1). The gold standard treatment for sleep-disordered breathing is continuous positive airway pressure (CPAP) therapy (2). However, nearly 30% of patients are considered non-adherent to CPAP treatment (3). Moreover, the number of hours of CPAP usage has been shown to be directly associated with a reduction in objective and subjective sleepiness, and improvement in daytime functioning (4). A recent prospective study conducted in a French clinical population cohort of 5138 participants found an effect of CPAP treatment duration on reducing the risk of developing a major cardiovascular event (stroke, myocardial infarction, all-cause mortality) (5). Therefore, the poor adherence to CPAP treatment represents a public health challenge for healthcare professionals managing these patients. Several predictors for non-adherence can be identified, such as using CPAP for less than 4 hours per night during the initial treatment phase, moderate to severe obstructive sleep apnea, or low self-esteem (6). Measures aimed at promoting patient adaptation from the initiation of treatment are crucial as this period determines long-term adherence to CPAP therapy (7). Among these measures, there is the management of "physical" adverse effects such as xerostomia (using a humidifier), feeling too much or too little air (modifying CPAP pressure profiles), skin problems, and mask air leaks (interface adjustment), which are well-known and applied by health care organization providing the CPAP machines (2).

On top of these "technical" problems, patients related issues such as mask-induced anxiety, psychosocial conditions, and dysfunctional thoughts about CPAP treatment may prevent patients from using their CPAP properly. Innovative tools such as psycho corporal therapies, including medical hypnosis, could be used in these situations. A recent literature review focusing on the impact of medical hypnosis on sleep disorders in adult patients found an improvement in various sleep parameters (sleep quality, insomnia complaints, frequency and/or intensity of parasomnias) in 58.4% of patients. However, in this systematic review of 24 studies, none of them explored the use of medical hypnosis in sleep-related breathing disorders (8).

Hypnosis can be defined as an altered state of consciousness in which a person's attention is detached from their immediate environment and absorbed in inner experiences such as feelings, cognition, and imagery (9). Hypnotic induction involves focusing attention and imaginative involvement to the point where what is imagined seems real. By using and accepting suggestions, the clinician and the patient create a benevolent hypnotic reality with the goal of improving the patient's clinical situation (10).

In the literature, there is only one clinical case report describing a benefit of medical hypnosis for CPAP tolerance in a child with cherubism (a rare fibro-osseous genetic disease-causing nasal obstruction). In this case, CPAP therapy using an oral interface was fully accepted after three hypnosis sessions and corrected the obstructive sleep breathing disorder (11). In a slightly different domain, there is a case report of successful use of medical hypnosis as an adjunct therapy for weaning from mechanical ventilation (12).

Our hypothesis is that the use of medical hypnosis in CPAP-treated patients could improve the patient's perception of the treatment, making it more positive. Medical hypnosis could occur very early in the management process, with rapid learning of self-hypnosis to actively influence this crucial period for long term adherence of CPAP. The principal objective is therefore to evaluate the effects of medical hypnosis on adherence to CPAP therapy in patients with sleep-disordered breathing.


Eligibility 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.

Primary outcomes:
measure: average hours of CPAP
timeFrame: Baseline after randomisation and at last visit 6 weeks after randomisation
Secondary outcomes:
measure: nights with CPAP use of more than 4 hours
timeFrame: Baseline after randomisation and at last visit 6 weeks after randomisation
measure: patients continuing to use CPAP
timeFrame: Baseline after randomisation and at last visit 6 weeks after randomisation
measure: sleepiness
timeFrame: Baseline after randomisation and at last visit 6 weeks after randomisation
measure: sleep quality
timeFrame: Baseline after randomisation and at last visit 6 weeks after randomisation
measure: Insomnia
timeFrame: Baseline after randomisation and at last visit 6 weeks after randomisation
measure: Score at the Quebec Sleep Questionnaire
timeFrame: Baseline after randomisation and at last visit 6 weeks after randomisation
measure: Anxiety and emotion
timeFrame: Baseline after randomisation and at last visit 6 weeks after randomisation
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: CHUVaudois
state: Vaud
Study officials:
References: