Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure.

NCT06397365 | Recruiting DMC

• 1 other identifier: CHUVaudois-HypnOSA
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Apnea Syndrome; Apnea, Obstructive

Keywords

CPAP adherence; medical hypnosis; obstructive sleep apnea

Outcome Measures

Primary Outcomes (1)

• average hours of CPAP

  average hours of CPAP use before and after the hypnosis therapy.

  Baseline after randomisation and at last visit 6 weeks after randomisation

Secondary Outcomes (7)

• nights with CPAP use of more than 4 hours

  Baseline after randomisation and at last visit 6 weeks after randomisation

• patients continuing to use CPAP

  Baseline after randomisation and at last visit 6 weeks after randomisation

• sleepiness

  Baseline after randomisation and at last visit 6 weeks after randomisation

• sleep quality

  Baseline after randomisation and at last visit 6 weeks after randomisation

• Insomnia

  Baseline after randomisation and at last visit 6 weeks after randomisation

Study Arms (2)

Hypnosis

EXPERIMENTAL

Baseline study visit (V1): signature of the informed consent form, verification of eligibility criteria, collection of demographic data, polygraphy or polysomnography features, data provided by the CPAP machine (one month), questionnaires. During the second visit (V2), the patient randomized in HYP group will come for the hypnosis sessions. Follow-up visit (V4): 28-42 days (4-6 weeks) after V3 for HYP group and 2 months (+/- 14 days) after V1 for SOC group. Collection of data provided by the CPAP machine (one month), questionnaires.

Other: medical hypnosis

standard of care

NO INTERVENTION

Baseline study visit (V1): signature of the informed consent form, verification of eligibility criteria, collection of demographic data, polygraphy or polysomnography features, data provided by the CPAP machine (one month), questionnaires. Usual management of CPAP treatment by the home care provider and the prescribing doctor without any change in management. Follow-up visit (V4): 28-42 days (4-6 weeks) after V3 for HYP group and 2 months (+/- 14 days) after V1 for SOC group. Collection of data provided by the CPAP machine (one month), questionnaires.

Interventions

medical hypnosis OTHER

The first hypnosis session (V2) consists of a safe place suggestion. Through this type of suggestions, patients will safely experience the dissociative state, and will be given tools (recordings of sessions) to perform self-hypnosis at home between the visits. The suggestions will help the patient to visualize an imaginary place where they feel well and safe, a protective place to rest. In this first session, CPAP treatment will be introduced during hypnosis, with specific suggestions relating to the use of this treatment. The second session (V3) The second session will also use the safe place. We will adapt the suggestions according to the experience reported by the patient on the day of the visit. During this session, we'll focus on changes in the patient's perception of the CPAP machine. Patients will also be given the recording of each session to perform self-hypnosis at home between the visits.

Hypnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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.

You may not qualify if:

• Patient's refusal to experience hypnosis.

Sponsors & Collaborators

• Solelhac Geoffroy: lead

Study Sites (1)

CHUVaudois

Lausanne, Canton of Vaud, 1011, Switzerland

RECRUITING

MeSH Terms

Conditions

Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: May 2, 2024
• Study Start: April 2, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)