Does Hypnosis Improve Severe Sleepwalking ? (HYPNOSOM)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Sleepwalking

Treatments: Behavioral: Hypnosis plus relaxation; Behavioral: Relaxation

Study type: Interventional

Funder types: Other

Identifiers

NCT02648568

P130603

2014-A00791-46 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 103 patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. >15 years old
2. French speaker
3. having signed the Informed consent form
4. Affiliated to National Health Insurance
5. Sleepwalking or sleep terrors (ICSD-3 criteria);
6. At least 2 awakenings from N3 on Night 1 videopolysomnography;
7. At least one episode per week.

Exclusion Criteria

1. < 15 years old
2. Patient under guardian ship
3. Patient unable to understand the protocol
4. Patient unable, from investigator's opinion, to comply to the procedures of the trial, including the ability to practice self-hypnosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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103 participants in 2 patient groups

Hypnosis plus relaxation

Active Comparator group

Description:

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)

Treatment:

Behavioral: Hypnosis plus relaxation

Relaxation

Active Comparator group

Description:

Jacobson relaxation, based on flexion and relaxation of muscles (serves here as a control procedure)

Treatment:

Behavioral: Relaxation