NREM ParasomniaNOCISOMNIENCT02906904
Pain Sensitivity in NREM Parasomnia (NOCISOMNIE)
A study testing Case Intervention in people with NREM Parasomnia and Sleepwalking, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- NREM Parasomnia, Sleepwalking, Sleep Terror
- What is being tested?
- Case Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
- Conditions
- NREM Parasomnia, Sleepwalking, Sleep Terror
- Being tested
- Case Intervention, Control Intervention
- Medical subject headings
- Somnambulism, Night Terrors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Case InterventionOther
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
Control InterventionOther
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
| Study group | Role | What they receive |
|---|---|---|
| CASE (adult sleepwalking patients) | Experimental | Not described Receives: Other: Case Intervention |
| CONTROL (adult healthy volunteers) | Experimental | Not described Receives: Other: Control Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of neurophysiological arousal response within 5 seconds after a subthreshold thermoalgic stimulation applied during parasomniac episodes.
Measured: within 5 seconds after stimulation
Secondary outcomes (3)
Temperature of the thermoalgic stimulation during wakefulness associated with a nociceptive perception of 5/10 on a visual analogic scale
Measured: on inclusion
Minimal temperature of thermoalgic stimulations associated with a neurophysiological arousal response in NREM sleep stage 2
Measured: within 5 seconds
Nociceptive behavioural response
Measured: within 5 seconds after a subthreshold thermoalgic stimulations applied during sleep and parasomniac episodes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2016 (estimated)
- Study startOct 2015 (estimated)
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Why it stopped: Material needed for study was not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NREM ParasomniaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02906904
- Sponsor's protocol ID
- 9540
- Acronym
- NOCISOMNIE
- Status last verified
- Jun 2018
- First submitted
- 6 Sep 2016
- Last updated
- 11 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Measures of Pain Sensitivity in NREM Sleep Parasomnia
- ClinicalTrials.gov ID
- NCT02906904
- Acronym / sponsor ID
- NOCISOMNIE / 9540
- Conditions
- NREM Parasomnia, Sleepwalking, Sleep Terror
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Material needed for study was not available
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Oct 2015 (estimated)
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 20 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CASE (adult sleepwalking patients) | Experimental | Other: Case Intervention |
| CONTROL (adult healthy volunteers) | Experimental | Other: Control Intervention |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Subject from 18 years-old to 45 years-old
- Affiliated to social security
- Written informed consent
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Case Intervention24-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 | Other | CASE (adult sleepwalking patients) |
| Control Intervention24-hour sleep deprivation protocol, polysomnographic monitoring of the recovery sleep, thermoalgic stimulation (Modulator Sensory Analyzer Thermal Stimulator®) during wakefulness, NREM stage 2 ans SWS | Other | CONTROL (adult healthy volunteers) |
Primary outcome
Percentage of neurophysiological arousal response within 5 seconds after a subthreshold thermoalgic stimulation applied during parasomniac episodes.
Time frame: within 5 seconds after stimulation
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Case Intervention in people with NREM Parasomnia and Sleepwalking, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of neurophysiological arousal response within 5 seconds after a subthreshold thermoalgic stimulation applied during parasomniac episodes. (time frame: within 5 seconds after stimulation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.