Pain Sensitivity in NREM Parasomnia (NOCISOMNIE) (NOCISOMNIE)

June 7, 2018 updated by: University Hospital, Montpellier

Objective Measures of Pain Sensitivity in NREM Sleep Parasomnia

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France
        • Montpellier University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of neurophysiological arousal response within 5 seconds after a subthreshold thermoalgic stimulation applied during parasomniac episodes.
Time Frame: within 5 seconds after stimulation
within 5 seconds after stimulation

Secondary Outcome Measures

Outcome Measure
Time Frame
Temperature of the thermoalgic stimulation during wakefulness associated with a nociceptive perception of 5/10 on a visual analogic scale
Time Frame: on inclusion
on inclusion
Minimal temperature of thermoalgic stimulations associated with a neurophysiological arousal response in NREM sleep stage 2
Time Frame: within 5 seconds
within 5 seconds
Nociceptive behavioural response
Time Frame: within 5 seconds after a subthreshold thermoalgic stimulations applied during sleep and parasomniac episodes
within 5 seconds after a subthreshold thermoalgic stimulations applied during sleep and parasomniac episodes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2015

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

June 11, 2018

Last Update Submitted That Met QC Criteria

June 7, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9540 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on NREM Parasomnia

Clinical Trials on Case Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cyprus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe