HealthyHypnopneeNCT02792738
Effect of Hypnosis on Dyspnea
A study testing hypnosis in people with Healthy and Dyspnea, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil at 1 site in France.
Trial summary
The purpose of this protocol is to test the effect of hypnosis on laboratory dyspnea. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2016to 13 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
Who cannot join
- pregnancy
- ongoing pain
- respiratory disease
- high levels of depression, panic disorder, or other significant mental health problems
- not fluent in french
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this protocol is to test the effect of hypnosis on laboratory dyspnea.
Read the detailed description
This is a study of permissive suggestion in two laboratory models of dyspnea ("work/effort", "air hunger"). Breathing discomfort rating induced by laboratory models of dyspnea will be assessed before, during and after hypnosis.
- Being tested
- hypnosis
- Medical subject headings
- Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnosisBehavioural
| Study group | Role | What they receive |
|---|---|---|
| hypnosis, visual distraction | Experimental | This is a crossover study in which each subject will be exposed to a 5 min phase of hypnotic suggestion and visual distraction.
For hypnotic suggestion, subject will be invited to experience a pleasant memory . Indirect and permissive suggestion will be used.
For visual distraction, subject will be watching the movie "la marche des empereurs" Receives: Behavioral: hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject rating of Breathing Discomfort (affective component of dyspnea)
Subjects will rate breathing discomfort using a visual analog scale at baseline (pre-intervention), during the intervention (hypnosis/ visual distraction) and after intervention (recovery) while subject will be submitted to the laboratory model of dyspnea for 5 minutes (three runs of laboratory dyspnea (baseline, intervention and recovery).
Measured: continuous measurement for 5 minutes
Subject rating of dyspnea intensity (sensory component of dyspnea)
Subjects will rate dyspnea intensity using a visual analog scale at baseline (pre-intervention), during the intervention (hypnosis/ visual distraction) and after intervention (recovery) while subject will be submitted to the laboratory model of dyspnea for 5 minutes (three runs of laboratory dyspnea (baseline, intervention and recovery).
Measured: continuous measurement for 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study start23 May 2016
- Primary completion13 Sep 2016
- Study completion13 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792738
- Sponsor's protocol ID
- ADOREPS_3
- Acronym
- Hypnopnee
- Status last verified
- Sep 2019
- First submitted
- 31 May 2016
- Last updated
- 16 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hypnosis on Dyspnea
- ClinicalTrials.gov ID
- NCT02792738
- Acronym / sponsor ID
- Hypnopnee / ADOREPS_3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le SommeilUniversity, hospital or other
- Study start
- 23 May 2016 (actual)
- Primary completion
- 13 Sep 2016 (actual)
- Study completion
- 13 Sep 2016 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this protocol is to test the effect of hypnosis on laboratory dyspnea.
Detailed description
This is a study of permissive suggestion in two laboratory models of dyspnea ("work/effort", "air hunger"). Breathing discomfort rating induced by laboratory models of dyspnea will be assessed before, during and after hypnosis.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hypnosis, visual distraction | Experimental | Behavioral: hypnosisThis is a crossover study in which each subject will be exposed to a 5 min phase of hypnotic suggestion and visual distraction. For hypnotic suggestion, subject will be invited to experience a pleasant memory . Indirect and permissive suggestion will be used. For visual distraction, subject will be watching the movie "la marche des empereurs" |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (5 listed)
- pregnancy
- ongoing pain
- respiratory disease
- high levels of depression, panic disorder, or other significant mental health problems
- not fluent in french
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypnosis | Behavioural | hypnosis, visual distraction |
Primary outcome
Subject rating of Breathing Discomfort (affective component of dyspnea)
Time frame: continuous measurement for 5 minutes
Subjects will rate breathing discomfort using a visual analog scale at baseline (pre-intervention), during the intervention (hypnosis/ visual distraction) and after intervention (recovery) while subject will be submitted to the laboratory model of dyspnea for 5 minutes (three runs of laboratory dyspnea (baseline, intervention and recovery).
Subject rating of dyspnea intensity (sensory component of dyspnea)
Time frame: continuous measurement for 5 minutes
Subjects will rate dyspnea intensity using a visual analog scale at baseline (pre-intervention), during the intervention (hypnosis/ visual distraction) and after intervention (recovery) while subject will be submitted to the laboratory model of dyspnea for 5 minutes (three runs of laboratory dyspnea (baseline, intervention and recovery).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypnosis in people with Healthy and Dyspnea, run by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 16 Sep 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject rating of Breathing Discomfort (affective component of dyspnea) (time frame: continuous measurement for 5 minutes). The study lists 2 primary outcomes in all. 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 16 Sep 2019.