AzTrials
AzTrials

Apnea SyndromeHypnOSANCT06397365

Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure.

A study testing medical hypnosis in people with Apnea Syndrome and Apnea, Obstructive, run by Solelhac Geoffroy at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Apnea Syndrome, Apnea, Obstructive
What is being tested?
medical hypnosis
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteSwitzerland
Study dates
2 Apr 2025to Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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.

Who cannot join

  • Patient's refusal to experience hypnosis.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland1 site, 1 recruiting
  • CHUVaudois

    Lausanne, Canton of Vaud, 1011

    Geoffroy Solelhac, MD, +41213146748, geoffroy.solelhac@chuv.ch

    Geoffroy Solelhac, MD

    Recruiting

Other trials in Switzerland

About this study

Official title: Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure Therapy in Sleep-disordered Breathing: a Randomized Controlled Trial

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).

Read more

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.

Being tested
medical hypnosis
Keywords
CPAP adherence, medical hypnosis, obstructive sleep apnea
Medical subject headings
Sleep Apnea Syndromes, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • medical hypnosisOther

    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.

Study groups in NCT06397365
Study groupRoleWhat they receive
HypnosisExperimentalBaseline 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.
Receives: Other: medical hypnosis
standard of careNo interventionBaseline 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. average hours of CPAP

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

    Measured: Baseline after randomisation and at last visit 6 weeks after randomisation

Secondary outcomes (7)
  1. nights with CPAP use of more than 4 hours

    percentage of nights with CPAP use of more than 4 hours before and after the hypnosis therapy

    Measured: Baseline after randomisation and at last visit 6 weeks after randomisation

  2. patients continuing to use CPAP

    percentage of patients continuing to use CPAP at the end of the study.

    Measured: Baseline after randomisation and at last visit 6 weeks after randomisation

  3. sleepiness

    Epworth Sleepiness Scale to evaluate daytime sleepiness. (0 to 24. The higher the score, the higher that person's average sleep propensity in daily life or their daytime sleepiness)

    Measured: Baseline after randomisation and at last visit 6 weeks after randomisation

  4. sleep quality

    Pittsburgh Sleep Quality Index to evaluate sleep quality over a 1-month period. (0 to 21 points, where 0 means that there are no difficulties, and 21 indicating major difficulties.)

    Measured: Baseline after randomisation and at last visit 6 weeks after randomisation

  5. Insomnia

    Evaluation of the diagnosis of chronic insomnia according to the Insomnia Severity Index.(0 to 28 :

    Total score categories:

    0-7 = No clinically significant insomnia 8-14 = Subthreshold insomnia 15-21 = Clinical insomnia (moderate severity) 22-28 = Clinical insomnia (severe))

    Measured: Baseline after randomisation and at last visit 6 weeks after randomisation

  6. Score at the Quebec Sleep Questionnaire

    Quebec Sleep Questionnaire to evaluate the quality of life related specifically to obstructive sleep apnea. The questionnaire assesses five domains: (1) hypersomnolence; (2) diurnal symptoms; (3) nocturnal symptoms; (4) emotions; and (5) social interactions. Each domain includes 4-7 items and each item is scored on a 7-point scale. For each domain, higher scores indicates milder symptoms.

    Measured: Baseline after randomisation and at last visit 6 weeks after randomisation

  7. Anxiety and emotion

    The Hospital Anxiety and Depression Scale to evaluate the psychological state. The scale is an instrument for screening for anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety and seven others to the depressive dimension. two scores (maximum score for each = 21). A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.

    Measured: Baseline after randomisation and at last visit 6 weeks after randomisation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2024
  2. Study start2 Apr 2025
  3. Primary completionFeb 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06397365
Sponsor's protocol ID
CHUVaudois-HypnOSA
Acronym
HypnOSA
Status last verified
Apr 2025
First submitted
23 Apr 2024
Last updated
4 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing medical hypnosis in people with Apnea Syndrome and Apnea, Obstructive, run by Solelhac Geoffroy at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

average hours of CPAP (time frame: Baseline after randomisation and at last visit 6 weeks after randomisation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in