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Chronic Obstructive Pulmonary Disease (COPD)HYPNODYSNCT07637604

Evaluation of the Benefits of Hypnosis in Improving the Quality of Life of Patients With Chronic Obstructive Pulmonary Disease (COPD) Suffering From Persistent Dyspnea

A study testing Hypnosis and standardized telephone calls in people with Chronic Obstructive Pulmonary Disease (COPD) and Dyspnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Chronic Obstructive pulmonary Disease (COPD) is a common progressive disorder characterized by persistent airflow limitation. It is usually caused by exposure to tobacco smoke, toxic particles, or toxic gases. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Hypnosis and standardized telephone calls
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
1 siteFrance
Study dates
1 Sep 2026to 15 Dec 2029
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

  • Age >18 years
  • COPD (any etiology), referred by a pulmonologist and managed according to GOLD 2024 guidelines except for pulmonary rehabilitation that is not required
  • Outpatient follow-up
  • Residing in Paris or the inner suburbs for centers located within the city limits, or within a 30-minute drive for centers located outside the city limits of Paris.
  • Dyspnea rated as mMRC 3 or 4
  • Having signed an informed consent form

Who cannot join

  • Vulnerable individuals (under legal guardianship or curatorship) or deprived of liberty
  • Pregnant or breastfeeding women
  • Absolute or relative contraindication to the 6 minutes walk test, spirometry or body plethysmography
  • Current COPD exacerbation or exacerbation resolved less than one week ago
  • Psychosis or other psychiatric disorder likely to interfere with study participation
  • Profound hearing impairment
Show all 15Show fewer
  • Cognitive impairment
  • Use of psychedelic substances (ex: LSD (Lysergic acid diethylamide), psilocybin, etc.)
  • Current participation in interventions that may be related to hypnosis: any kind of meditation, relaxation, sophrology, heart coherence training, yoga, Qi Gong, holotropic breathing, EMDR (Eye Movement Desensitization and Reprocessing) or any psychotherapies involving eye movements, as well as shamanic practices and brief psychotherapies or cognitive-behavioral therapies
  • Previous management of dyspnea using hypnosis
  • Ongoing pulmonary rehabilitation (physiotherapy outside a structured rehabilitation program initiated before study inclusion is not an exclusion criterion)
  • Inability to be reached by phone or teleconsultation
  • Lack of health insurance (French social security) coverage
  • Participation in another clinical trial
  • End of life

Trial locations and contacts

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

Christian STRAUS, MD, PHD contact

+331 42 17 85 78

christian.straus@aphp.fr

Marthe MAHI, Master contact

+331 42 16 16 99

marthe.mahi@aphp.fr

France1 site
  • APHP, Hôpital Pitié-Salpêtrière

    Paris, France, 75013

    Christian STRAUS, MD, PHD, +331 42 17 85 78, christian.straus@aphp.fr

    Marthe MAHI, Master, +331 42 16 16 99, marthe.mahi@aphp.fr

Other trials in France

About this study

Official title: Evaluation of the Benefits of Hypnosis in Improving the Quality of Life of Patients With Chronic Obstructive Pulmonary Disease (COPD) Suffering From Persistent Dyspnea: a Multicenter Randomized Controlled Trial

Chronic Obstructive pulmonary Disease (COPD) is a common progressive disorder characterized by persistent airflow limitation. It is usually caused by exposure to tobacco smoke, toxic particles, or toxic gases. COPD is characterized by cough, sputum production, and dyspnea, which is the cardinal symptom and is included in the criteria for severity. Dyspnea is a major source of suffering and disability, especially when it persists at rest.

Despite proper medical treatment, many patients continue to suffer from persistent dyspnea that significantly impairs their daily functioning and quality of life. Complementary approaches such as yoga and relaxation techniques are therefore recommended by some experts. Hypnosis is one of these practices. It has been shown to be effective in the management of both acute and chronic pain and it can abolish several types of experimentally induced dyspnea in healthy volunteers. In adults with COPD, a single hypnosis session has been shown to reduce anxiety immediately, though only temporarily. However, according to a recent retrospective study, a median of three hypnosis sessions increases the distance covered in the 6-minute walk test in COPD patients.

The investigators therefore hypothesize that several hypnosis sessions will improve the quality of life of adult outpatients with COPD who suffer from persistent dyspnea. The study plans to recruit 154 patients with severe dyspnea (mMRC(modified Medical Research Council Dyspnea Scale) 3 or 4). They will be randomly assigned to either the experimental group or the control group. Patients in the experimental group will participate in 5 sessions of medical hypnosis spaced 7 ± 2 days apart. The first hypnosis session will take place at the end of the enrollment visit. The final session will be held via teleconsultation. Four standardized telephone calls, spaced 7 ± 2 days apart, will replace the hypnosis sessions in the control group. The primary outcome of the study will be the evolution of quality of life, assessed 6 weeks after the start of the study as compared to baseline. Secondary outcomes will focus on changes in exercise capacity, dyspnea, anxiety, depression, dyspnea-related catastrophizing, self-efficacy, and pleasure in life.

Read the detailed description

The study aims at assessing the effect of medical hypnosis on the quality of life of dyspneic COPD outpatients. It plans to recruit 154 COPD outpatients with severe dyspnea (mMRC 3 or 4). They will have to be treated in accordance with the GOLD (Global Initiative for Chronic Obstructive Lung Disease) 2024 guidelines, exept for pulmonary rehabilitation that is not required. Inclusion and non-inclusion criteria are provided below. Patients will be randomly assigned to either the experimental or the control group. Patients in the experimental group will participate in 5 sessions of medical hypnosis spaced 7 ± 2 days apart. The first hypnosis session will take place at the end of the enrollment visit. The final session will be held via teleconsultation. Four standardized telephone calls, spaced 7 ± 2 days apart, will replace the hypnosis sessions in the control group. The objectives of the study will be assessed 6 weeks after enrollment. The primary objective of this study will be to evaluate the benefit of hypnosis in improving the quality of life of outpatients with COPD and persistent dyspnea, compared to a control group that will receive support through standardized telephone calls but no hypnosis.

The primary outcome will be the change in the total score of the St George's Respiratory Questionnaire (SGRQ) which assesses respiratory related quality of life, measured 6 weeks after randomization.

The secondary objectives of the study will be to evaluate the benefit of hypnosis in patients with COPD and persistent dyspnea compared to the control group on the following outcomes:

  1. The components of quality of life in COPD: symptoms, activity, and impact on daily life. Those components are part of the SGRQ.
  2. The ability to engage in physical activity. It will will be assessed with the 6-min walk test.
  3. Dyspnea and its affective, sensory, and emotional dimensions. They will be assessed using the multidimensional dypnea profile (MDP) questionnaire. d) Dyspnea in activities of daily living. It will be assessed using the London Chest Activity of Daily Living (LCADL) scale.
  4. The level of anxiety. It will be assessed using the Hospital Anxiety and Depression Scale (HADS).
  5. The level of depression. It will also be assessed using the Hospital Anxiety and Depression Scale (HADS).
  6. The level of catastrophizing about dyspnea. It will be assessed using the breathlessness catastrophizing scale for chronic obstructive pulmonary disease.
  7. The level of self-efficacy. It will be assessed using the COPD Self-Efficacy Scale.
  8. The level of pleasure (or the level of anhedonia). It will be assessed using the Snaith-Hamilton Pleasure Scale.
Being tested
Hypnosis, standardized telephone calls
Keywords
Chronic Obstructive Pulmonary Disease (COPD), Dyspnea,, Hypnosis
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Dyspnea

What participants receive

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

  • HypnosisBehavioural

    Five medical hypnosis sessions, each scheduled 7 ± 2 days apart

  • standardized telephone callsOther

    Four standardized telephone calls, made at 7 ± 2 day intervals

Study groups in NCT07637604
Study groupRoleWhat they receive
HypnosisExperimentalFive medical hypnosis sessions, each scheduled 7 ± 2 days apart
Receives: Behavioral: Hypnosis
controlOtherFour standardized telephone calls, made at 7 ± 2 day intervals
Receives: Other: standardized telephone calls

What is being measured

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

  1. Change in quality of life assessed using the total score of the St George's Respiratory Questionnaire (SGRQ)

    Change in the total score of the St. George's Respiratory Questionnaire (SGRQ), which assesses respiration-related quality of life, at 6 weeks after randomization and baseline. The SGRQ is a self-administered questionnaire that assesses three domains: symptoms, activity, and impact on daily life. It permits calculation of a total score from these three domains, reflecting respiration-related quality of life. Study participants will complete this questionnaire at the first visit, the randomization visit (V1), and the final visit (V6). The two visits will take place 6 weeks apart (with an extra week's buffer in case of unexpected delays regarding one of the visits or hypnosis sessions). (Total score ranges from 0 to 100, 0 = no impact of the disease on quality of life, 100 = maximum impact on quality of life.

    Measured: 6 weeks

Secondary outcomes (8)
  1. Change in the three component scores of the SGRQ that assess the quality of life in COPD in terms of symptoms, activity and impact on daily life

    The SGRQ permits the calculation of 3 scores related to the quality of life in COPD patients : symptoms, activity and impact on daily life (Total score ranges from 0 to 100, 0 = no impact of the disease on quality of life, 100 = maximum impact on quality of life.).

    Measured: 6 weeks

  2. Change in ability to engage in physical activity

    Distance covered during the 6-minute walk test

    Measured: 6 weeks

  3. Change in dyspnea and its affective, sensory, and emotional dimensions

    Dyspnea will be assessed using the Multidimensional Dyspnea Profile (MDP) questionnaire (Scores range from 0 to 10-50 for each item with higher scores indicating more severe sensory or emotional dyspnea; 0 = no impact of breathlessness.).

    Measured: 6 weeks

  4. Change in dyspnea in activities of daily living

    Dyspnea will be assessed using the London Chest Activity of Daily Living (LCADL) scale (Scores range from 0 to 75, 0 = no limitation of daily activities due to breathlessness. 75 = maximum limitation of daily activities due to breathlessness.).

    Measured: 6 weeks

  5. Changes in levels of anxiety and depression

    The levels of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS) (Scores range from 0 to 21 for each subscale, with higher scores indicating more severe anxiety or depressive symptoms, 0-7 = Normal, 11-21 = Probable case of anxiety/depression).

    Measured: 6 weeks

  6. Change in level of catastrophizing about dyspnea

    The level of catastrophizing about dyspnea will be assessed using the breathlessness catastrophizing scale (Scores range from 0 to 52, A score of 0 indicates no catastrophizing, whereas a score of 52 indicates maximal catastrophizing) for chronic obstructive pulmonary disease

    Measured: 6 weeks

  7. Change in level of self-efficacy in COPD

    The level of self-efficacy will be assessed using the COPD Self-Efficacy Scale (Scores range from 34 to 170, 34= lowest perceived self-efficacy, 170= greatest perceived self-efficacy).

    Measured: 6 Weeks

  8. Change in level of pleasure (or the level of anhedonia)

    The level of pleasure will be assessed using the Snaith-Hamilton Pleasure Scale (Scores range from 0 to 14, 0 = no anhedonia, 14= greatest anhedonia or lowest experienced pleasure).

    Measured: 6 weeks

Timeline

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

  1. First posted10 Jun 2026
  2. Study start1 Sep 2026 (estimated)
  3. Primary completion1 Oct 2029 (estimated)
  4. Study completion15 Dec 2029 (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
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07637604
Sponsor's protocol ID
APHP251231
Other IDs
N° IDRCB: 2025-A02601-48
Acronym
HYPNODYS
Status last verified
May 2026
First submitted
19 May 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Due to the procedures approved by the French data privacy authority (Commission nationale de l'informatique et des libertés - CNIL), and the content of the informed consent forms signed by participants, full database transmission is not authorized. However, consultation of deidentified individual participant data may be considered for editorial boards or qualified researchers, upon reasonable request and under strict regulatory safeguards, subject to prior agreement on terms and conditions of access.

Questions about this trial

What is this clinical trial studying?

A study testing Hypnosis and standardized telephone calls in people with Chronic Obstructive Pulmonary Disease (COPD) and Dyspnea, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 6 inclusion and 15 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: opening soon, as of the sponsor's last update on 10 Jun 2026. 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 France. 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?

Contact Christian STRAUS, MD, PHD (+331 42 17 85 78, christian.straus@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in quality of life assessed using the total score of the St George's Respiratory Questionnaire (SGRQ) (time frame: 6 weeks). 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 10 Jun 2026.

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