Groupe Hospitalier Pitié-Salpétrière
Paris, 75013, France
NCT Number: NCT02648568
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.
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Notify Me15 year and older
All sexes
Interventional
Not applicable
Paris, 75013, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
The patient will have 20 min of Jacobson 's type relaxation, with sequential contraction and relaxation of limb muscles
Other names: Jacobson type relaxation
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)
Time frame: At one and at three months
total PADSS score
Time frame: Night 2 (8 hours) and at one month (long term)
Number of N3 awakenings
Time frame: Night 2 (8 hours) and at one month (long term)
scale of behaviors on videopSG
Time frame: Night 2 (8 hours) and at one month (long term)
sleep stages (% of total sleep time)
Time frame: Night 2 (8 hours) and at one month (long term)
total sleep time in minute
Time frame: Night 2 (8 hours) and at one month (long term)
ratio between total sleep time and total sleep period
Time frame: At night 1 (8 hours)
Spectral EEG analysis during hypnotic trance, rest, relaxation and N3 awakenings
Time frame: At night 1 (8 hours)
EOG during rest, hypnotic trance, relaxation, and N3 awakenings
Time frame: At night 1 (8 hours)
chin EMG during rest, hypnotic trance, relaxation, and N3 awakenings
Time frame: At night 1 (8 hours)
Respiratory rate and amplitude via impedance belts during rest, hypnotic trance, relaxation, and N3 awakenings
Time frame: At night 1 (8 hours)
heart rate via ECG during rest, hypnotic trance, relaxation, and N3 awakenings
Time frame: at three months (very 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)
Time frame: At night 1 (8 hours)
Per % of tonic and phasic enhanced muscle tone during REM sleep
Assistance Publique - Hôpitaux de Paris
Other
Acronym: HYPNOSOM
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