Pain Sensitivity in NREM Parasomnia (NOCISOMNIE) (NOCISOMNIE)
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|ClinicalTrials.gov Identifier: NCT02906904|
Recruitment Status : Withdrawn (Material needed for study was not available)
First Posted : September 20, 2016
Last Update Posted : June 11, 2018
Non Rapid Eye Movement (NREM) sleep parasomnias (sleepwalking and sleep terrors) are frequent and disabling sleep disorders characterized by arousal specifically from slow wave sleep (SWS) with dissociated brain activity that may be related to lower nociceptive state. The investigators recently reported frequent subjective complaints of chronic pain, migraine and headache during wakefulness in adult sleepwalkers. They also described frequent analgesia during severe and injuring episodes, suggesting a relationship between dissociated brain activity and nociceptive dysregulation. However, this study did not included objective nociceptive measures and the retrospective assessment of perceived pain during parasomnia episodes over a lifetime span might also introduce a recall bias.
The aims of the present study are to measure objective pain sensitivity in patients with NREM parasomnias and matched controls during 1) parasomniac episodes, 2) light NREM sleep and SWS, and 3) wakefulness.
Fifteen adults with severe NREM parasomnia and 15 age and sex-matched controls will be recruited. A 25 hours (8 AM to 9 AM) sleep deprivation protocol followed by auditory stimulations during SWS will be used to trigger parasomniac episodes. Thermoalgic stimulations of graduate intensity will be applied during wakefulness (8 PM) to determine the nociceptive threshold. During the recovery sleep following the sleep deprivation, the investigators will apply repeated subthreshold thermoalgic stimulations in NREM stage 2, SWS and triggered parasomniac episodes and report the behavioural/neurophysiologic nociceptive responses.
The investigators hypothesized a lower nociceptive threshold during wakefulness in sleepwalkers and a decrease of the arousabiliy during SWS and parasomniac episodes. This study may help to better understand the etiology and mechanisms underlying the clinical enigma of the nociceptive dysregulation in NREM sleep parasomnias.
|Condition or disease||Intervention/treatment||Phase|
|NREM Parasomnia Sleepwalking Sleep Terror||Other: Case Intervention Other: Control Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Objective Measures of Pain Sensitivity in NREM Sleep Parasomnia|
|Estimated Study Start Date :||October 2015|
|Estimated Primary Completion Date :||October 2017|
|Estimated Study Completion Date :||October 2017|
|Experimental: CASE (adult sleepwalking patients)||
Other: Case Intervention
24-hour sleep deprivation protocol, polysomnographic monitoring of the recovery sleep, triggering of parasomniac episodes by auditory stimulations, thermoalgic stimulation (Modulator Sensory Analyzer Thermal Stimulator®) during wakefulness, parasomniac episodes, NREM stage 2 ans SWS
|Experimental: CONTROL (adult healthy volunteers)||
Other: Control Intervention
24-hour sleep deprivation protocol, polysomnographic monitoring of the recovery sleep, thermoalgic stimulation (Modulator Sensory Analyzer Thermal Stimulator®) during wakefulness, NREM stage 2 ans SWS
- Percentage of neurophysiological arousal response within 5 seconds after a subthreshold thermoalgic stimulation applied during parasomniac episodes. [ Time Frame: within 5 seconds after stimulation ]
- Temperature of the thermoalgic stimulation during wakefulness associated with a nociceptive perception of 5/10 on a visual analogic scale [ Time Frame: on inclusion ]
- Minimal temperature of thermoalgic stimulations associated with a neurophysiological arousal response in NREM sleep stage 2 [ Time Frame: within 5 seconds ]
- Nociceptive behavioural response [ Time Frame: within 5 seconds after a subthreshold thermoalgic stimulations applied during sleep and parasomniac episodes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906904
|Montpellier University Hospital|