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Pain Sensitivity in NREM Parasomnia (NOCISOMNIE) (NOCISOMNIE)

This study is not yet open for participant recruitment.
Verified September 2016 by University Hospital, Montpellier
Sponsor:
ClinicalTrials.gov Identifier:
NCT02906904
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Montpellier
  Purpose

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 Intervention
NREM Parasomnia Sleepwalking Sleep Terror Other: Case Intervention Other: Control Intervention

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Objective Measures of Pain Sensitivity in NREM Sleep Parasomnia

Resource links provided by NLM:


Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Percentage of neurophysiological arousal response within 5 seconds after a subthreshold thermoalgic stimulation applied during parasomniac episodes. [ Time Frame: within 5 seconds after stimulation ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 30
Study Start Date: September 2016
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject from 18 years-old to 45 years-old
  • Affiliated to social security
  • Written informed consent

    * CASE specific inclusion criteria :

  • NREM parasomnia diagnosed according to the International Classification of Sleep Disorders 3rd edition (ICSD-3) criteria and confirmed by polysomnography assessment
  • Frequent symptomatology (at least 1 episode by week in the past 3 months)

    * CONTROL specific inclusion criteria :

  • No medical history of NREM parasomnia

Exclusion Criteria:

  • Known skin allergy to metal
  • Use of psychotropic drugs during the 15 days before the inclusion
  • Use of analgesic drugs during the 15 days before the inclusion
  • A diagnosis of sleep apnea syndrome, periodic limb movements or restless legs syndrome present more than twice a week
  • Medical history of epilepsy
  • Non stable psychiatric disorder
  • Pregnancy, breastfeeding
  • Subject deprived of liberty or protected by law (tutorship, curatorship).
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
France
Montpellier University Hospital Not yet recruiting
Montpellier, France
Contact: Régis LOPEZ       r-lopez@chu-montpellier.fr   
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02906904     History of Changes
Other Study ID Numbers: 9540
First Submitted: September 6, 2016
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Somnambulism
Parasomnias
Sleep Wake Disorders
Night Terrors
Sleep Arousal Disorders
Nervous System Diseases
Mental Disorders
Neurologic Manifestations
Signs and Symptoms