SleepwalkingHYPNOSOMNCT02648568
Does Hypnosis Improve Severe Sleepwalking ?
A study testing Hypnosis plus relaxation and Relaxation in people with Sleepwalking, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to compare the benefit of two cognitive therapies in severe sleepwalking/ sleep terrors: relaxation vs. relaxation plus hypnosis. This is a monocentric, double-blind controlled study. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Sleepwalking
- What is being tested?
- Hypnosis plus relaxation and Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2015to Dec 2017
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- >15 years old
- French speaker
- having signed the Informed consent form
- Affiliated to National Health Insurance
- Sleepwalking or sleep terrors (ICSD-3 criteria);
- At least 2 awakenings from N3 on Night 1 videopolysomnography;
- At least one episode per week.
Who cannot join
- < 15 years old
- Patient under guardian ship
- Patient unable to understand the protocol
- Patient unable, from investigator's opinion, to comply to the procedures of the trial, including the ability to practice self-hypnosis.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the study is to compare the benefit of two cognitive therapies in severe sleepwalking/ sleep terrors: relaxation vs. relaxation plus hypnosis. This is a monocentric, double-blind controlled study. 75 patients (aged more than 15 yo) with severe sleepwalking (defined as at least one epsidoe per week and at least two awakenings in stage N3 on video polysomngraphy) will be included. All patients will have a visit 1 for diagnosis including a medical interview, a video polysomnography, questionnaires on sleepwalking (PADSS and systematized interview), sleep quality (PSQI, MEQ) and sleepiness (Epworth scale) and suggestibility scale. 25 patients will be randomized to the relaxation group, 25 patients to the hypnosis plus relaxation group, while the 25 non-randomized patients will be non-treated controls. Randomized patients will receive the therapy on day 1, and be monitored during the subsequent night. They will have a weekly therapy for 4 additional sessions and be monitored again on Month 1, as well as they will complete the sleep and sleepwalking questionnaires. They will also complete the questionnaire by phone on Month 3. The non-randomized controls will complete the questionnaire on month 1, with no therapeutical intervention between Day 1 and Month 1. The main outcome will be the frequency of sleepwalking episodes, as assessed by the PADSS-B. Secondary outcomes include the changes in other subitems of teh PADSS, of the N3 awakenings in v-PSG between night 1 and Night 2 (short term effect) and Night 1 and Night 28 (long term effect), as well as changes in sleep quality and sleepiness scales. A comparison of spectral EEG, as well as respiration, eye movements, muscle tone and heart rate during rest, hypnosis trance, relaxation and sleepwalking episodes is also scheduled.
Read the detailed description
Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures
- Conditions
- Sleepwalking
- Being tested
- Hypnosis plus relaxation, Relaxation
- Keywords
- Sleepwalking, sleep terrors, arousal disorders, F513 (CIM-10), F514 (CIM-10)
- Medical subject headings
- Somnambulism, Night Terrors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis plus relaxationBehavioural
The patient will have 20 min of Jacobson 's type relaxation, with sequential contraction and relaxation of limb muscles followed by an induction of hypnosis based on the preferential channel of each patient and, during trance, recommendation to assimilter the bed room and bed to a safe place
RelaxationBehavioural
Also called Jacobson type relaxation
The patient will have 20 min of Jacobson 's type relaxation, with sequential contraction and relaxation of limb muscles
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis plus relaxation | Active comparator | Ericksonian hypnosis, based on sensations when awakening partially during N3 ; Jacobson relaxation, based on flexion and relaxation of muscles (serves here as a control procedure) Receives: Behavioral: Hypnosis plus relaxation |
| Relaxation | Active comparator | Jacobson relaxation, based on flexion and relaxation of muscles (serves here as a control procedure) Receives: Behavioral: Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of sleepwalking episodes as assessed by the PADSS-B
PADSS-B questionnaire, including the frequency of sleepwalking/sleep terrors episodes as evaluated by the patients, from none(0) to (several par nights (6)
Measured: at one month (long term)
Secondary outcomes (13)
Other subjective characteristics of sleepwalking/sleep terrors
total PADSS score
Measured: At one and at three months
Objective measures of sleepwalking: number of N3 awakenings
Number of N3 awakenings
Measured: Night 2 (8 hours) and at one month (long term)
Objective measures of sleepwalking :behaviors on videoPSG
scale of behaviors on videopSG
Measured: Night 2 (8 hours) and at one month (long term)
% of sleep stages
sleep stages (% of total sleep time)
Measured: Night 2 (8 hours) and at one month (long term)
total sleep time
total sleep time in minute
Measured: Night 2 (8 hours) and at one month (long term)
sleep efficiency
ratio between total sleep time and total sleep period
Measured: Night 2 (8 hours) and at one month (long term)
Spectral EEG (power)
Spectral EEG analysis during hypnotic trance, rest, relaxation and N3 awakenings
Measured: At night 1 (8 hours)
Eye movements (number per minute)
EOG during rest, hypnotic trance, relaxation, and N3 awakenings
Measured: At night 1 (8 hours)
Muscle tone (amplitude in microvolt)
chin EMG during rest, hypnotic trance, relaxation, and N3 awakenings
Measured: At night 1 (8 hours)
Respiration (Rate of breathing per minute)
Respiratory rate and amplitude via impedance belts during rest, hypnotic trance, relaxation, and N3 awakenings
Measured: At night 1 (8 hours)
Heart rate (beats per minutes)
heart rate via ECG during rest, hypnotic trance, relaxation, and N3 awakenings
Measured: At night 1 (8 hours)
Frequency of sleepwalking episodes as assessed by the PADSS-B
PADSS-B questionnaire, including the frequency of sleepwalking/sleep terrors episodes as evaluated by the patients, from none(0) to (several par nights (6)
Measured: at three months (very long term)
REM sleep without atonia
Per % of tonic and phasic enhanced muscle tone during REM sleep
Measured: At night 1 (8 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2016 (estimated)
- Study startJan 2015
- Primary completionNov 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SleepwalkingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ARNULF Isabelle, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02648568
- Sponsor's protocol ID
- P130603
- Other IDs
- 2014-A00791-46
- Acronym
- HYPNOSOM
- Status last verified
- Sep 2017
- First submitted
- 15 Dec 2015
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Barros A, Uguccioni G, Salkin-Goux V, Leu-Semenescu S, Dodet P, Arnulf I. Simple behavioral criteria for the diagnosis of disorders of arousal. J Clin Sleep Med. 2020 Jan 15;16(1):121-128. doi: 10.5664/jcsm.8136. Epub 2019 Dec 4.
PubMed 31957639Dubessy AL, Leu-Semenescu S, Attali V, Maranci JB, Arnulf I. Sexsomnia: A Specialized Non-REM Parasomnia? Sleep. 2017 Feb 1;40(2). doi: 10.1093/sleep/zsw043.
PubMed 28364495
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Hypnosis Improve Severe Sleepwalking ?
- ClinicalTrials.gov ID
- NCT02648568
- Acronym / sponsor ID
- HYPNOSOM / P130603
- Conditions
- Sleepwalking
- Keywords
- Sleepwalking, sleep terrors, arousal disorders, F513 (CIM-10), F514 (CIM-10)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Nov 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 7 Jan 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 aim of the study is to compare the benefit of two cognitive therapies in severe sleepwalking/ sleep terrors: relaxation vs. relaxation plus hypnosis. This is a monocentric, double-blind controlled study. 75 patients (aged more than 15 yo) with severe sleepwalking (defined as at least one epsidoe per week and at least two awakenings in stage N3 on video polysomngraphy) will be included. All patients will have a visit 1 for diagnosis including a medical interview, a video polysomnography, questionnaires on sleepwalking (PADSS and systematized interview), sleep quality (PSQI, MEQ) and sleepiness (Epworth scale) and suggestibility scale. 25 patients will be randomized to the relaxation group, 25 patients to the hypnosis plus relaxation group, while the 25 non-randomized patients will be non-treated controls. Randomized patients will receive the therapy on day 1, and be monitored during the subsequent night. They will have a weekly therapy for 4 additional sessions and be monitored again on Month 1, as well as they will complete the sleep and sleepwalking questionnaires. They will also complete the questionnaire by phone on Month 3. The non-randomized controls will complete the questionnaire on month 1, with no therapeutical intervention between Day 1 and Month 1. The main outcome will be the frequency of sleepwalking episodes, as assessed by the PADSS-B. Secondary outcomes include the changes in other subitems of teh PADSS, of the N3 awakenings in v-PSG between night 1 and Night 2 (short term effect) and Night 1 and Night 28 (long term effect), as well as changes in sleep quality and sleepiness scales. A comparison of spectral EEG, as well as respiration, eye movements, muscle tone and heart rate during rest, hypnosis trance, relaxation and sleepwalking episodes is also scheduled.
Detailed description
Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis plus relaxation | Active comparator | Behavioral: Hypnosis plus relaxationEricksonian hypnosis, based on sensations when awakening partially during N3 ; Jacobson relaxation, based on flexion and relaxation of muscles (serves here as a control procedure) |
| Relaxation | Active comparator | Behavioral: RelaxationJacobson relaxation, based on flexion and relaxation of muscles (serves here as a control procedure) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- >15 years old
- French speaker
- having signed the Informed consent form
- Affiliated to National Health Insurance
- Sleepwalking or sleep terrors (ICSD-3 criteria);
Key exclusion criteria (4 listed)
- < 15 years old
- Patient under guardian ship
- Patient unable to understand the protocol
- Patient unable, from investigator's opinion, to comply to the procedures of the trial, including the ability to practice self-hypnosis.
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 plus relaxationThe patient will have 20 min of Jacobson 's type relaxation, with sequential contraction and relaxation of limb muscles followed by an induction of hypnosis based on the preferential channel of each patient and, during trance, recommendation to assimilter the bed room and bed to a safe place | Behavioural | Hypnosis plus relaxation |
| RelaxationAlso: Jacobson type relaxationThe patient will have 20 min of Jacobson 's type relaxation, with sequential contraction and relaxation of limb muscles | Behavioural | Relaxation |
Primary outcome
Frequency of sleepwalking episodes as assessed by the PADSS-B
Time frame: at one month (long term)
PADSS-B questionnaire, including the frequency of sleepwalking/sleep terrors episodes as evaluated by the patients, from none(0) to (several par nights (6)
13 secondary outcomes
Other subjective characteristics of sleepwalking/sleep terrors
Time frame: At one and at three months
Objective measures of sleepwalking: number of N3 awakenings
Time frame: Night 2 (8 hours) and at one month (long term)
Objective measures of sleepwalking :behaviors on videoPSG
Time frame: Night 2 (8 hours) and at one month (long term)
% of sleep stages
Time frame: Night 2 (8 hours) and at one month (long term)
total sleep time
Time frame: Night 2 (8 hours) and at one month (long term)
sleep efficiency
Time frame: Night 2 (8 hours) and at one month (long term)
Spectral EEG (power)
Time frame: At night 1 (8 hours)
Eye movements (number per minute)
Time frame: At night 1 (8 hours)
Muscle tone (amplitude in microvolt)
Time frame: At night 1 (8 hours)
Respiration (Rate of breathing per minute)
Time frame: At night 1 (8 hours)
Heart rate (beats per minutes)
Time frame: At night 1 (8 hours)
Frequency of sleepwalking episodes as assessed by the PADSS-B
Time frame: at three months (very long term)
REM sleep without atonia
Time frame: At night 1 (8 hours)
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 8 Dec 2017.
- Derived from this study: PubMed 31957639Barros A, Uguccioni G, Salkin-Goux V, Leu-Semenescu S, Dodet P, Arnulf I. Simple behavioral criteria for the diagnosis of disorders of arousal. J Clin Sleep Med. 2020 Jan 15;16(1):121-128. doi: 10.5664/jcsm.8136. Epub 2019 Dec 4.
- Derived from this study: PubMed 28364495Dubessy AL, Leu-Semenescu S, Attali V, Maranci JB, Arnulf I. Sexsomnia: A Specialized Non-REM Parasomnia? Sleep. 2017 Feb 1;40(2). doi: 10.1093/sleep/zsw043.
- Individual participant dataSharing planned: No
Related trials for Sleepwalking
Not yet recruiting
Acoustic Stimulation to Study and Modulate Sleepwalking and Related Arousal Disorders
NREM Parasomnias, Sleepwalking
Recruiting
Development and Online Evaluation of an Online Course for Parasomnias
Sleep Terror, Sleepwalking
RecruitingObservational study
Mainz Register of Patients With Sleep Disorders
Sleep Disorder, Sleep Disorder Parasomnia
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.
ARNULF Isabelle, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
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 plus relaxation and Relaxation in people with Sleepwalking, 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 7 inclusion and 4 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 8 Dec 2017. 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?
Frequency of sleepwalking episodes as assessed by the PADSS-B (time frame: at one month (long term)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02648568, which also lists 2 linked publications.
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 8 Dec 2017.