Narcolepsy 1PNPNCT03356938
The Role of the Circadian System in Neurological Sleep-wake Disorders
A study testing Sleep restriction and Sleep deprivation in people with Narcolepsy 1 and Idiopathic Hypersomnia, run by Esther Werth at 1 site in Switzerland.
Trial summary
The aim of this study is to investigate the role of the circadian system in patients with neurologic sleep-wake disorders. Therefore, overnight sleep will be distributed over 30 hours into repetitive sleep-wake cycles (poly-nap protocol), so that sleep episodes occur at different circadian phases. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Narcolepsy 1, Idiopathic Hypersomnia
- What is being tested?
- Sleep restriction and Sleep deprivation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSwitzerland
- Study dates
- 28 Nov 2017to 31 May 2020
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and Female participants 18 years to 35 years of age
- Written informed consent by the participant after information about the research project
- Healthy controls: 7-8 hours of sleep per night
- Healthy controls: sleep satiation before start of the study
- Narcolepsy type 1: diagnosis of narcolepsy with cataplexy, drug free during study, proven excessive daytime sleepiness with increased REM (MSLT), clear-cut cataplexy present, undetectable or low cerebrospinal fluid hypocretin levels (if data is available)
- Idiopathic hypersomnia: diagnosis of idiopathic hypersomnia, drug free during study, proven excessive daytime sleepiness without increased REM (MSLT), increased sleep need (>10h/day) on work-free days shown by 2-week actigraphy
Who cannot join
- signs of neurological, psychiatric, or other sleep-wake disorders
- signs of sleep deprivation
- shift work and time zone change of more than one hour within one month prior the study start
- extreme morning and evening types
- underweight
- obstructive gastro-intestinal disease or history of gastrointestinal surgery
- an implanted medical device or a scheduled MRI scan during the experimental period
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of the Circadian System in Neurological Sleep-wake Disorders: Assessment of Circadian and Homeostatic Sleep-wake Regulation and Vigilance With a Poly-nap Protocol
The aim of this study is to investigate the role of the circadian system in patients with neurologic sleep-wake disorders. Therefore, overnight sleep will be distributed over 30 hours into repetitive sleep-wake cycles (poly-nap protocol), so that sleep episodes occur at different circadian phases. Vigilance, attention, risk behavior as well as sleep onset latency will be observed.
Ambulatory accelerometer recordings gain more and more attention in the diagnostic work-up of sleep disorders, as they allow to also include the everyday rest-activity rhythm before examinations in the sleep laboratory. Advances of novel devices should improve the detection of rest and activity and therefore the estimation of sleep and wake, especially in patients with neurologic sleep-wake disorders exhibiting fragmented sleep. Two types of actimeters will be applied throughout our study protocol to explore better classification of sleep and wake phases and patterns of the rest-activity rhythm.
This study is designed as an observational case-controlled study targeting the disorders of narcolepsy type 1 and idiopathic hypersomnia, and including interventional procedures in the healthy control group (sleep deprivation, sleep restriction) in a counter-balanced design.
- Conditions
- Narcolepsy 1, Idiopathic Hypersomnia
- Being tested
- Sleep restriction, Sleep deprivation
- Medical subject headings
- Narcolepsy 1, Idiopathic Hypersomnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep restrictionBehavioural
Restricted sleep to 5 hours / night for 5 days prior to sleep laboratory examination
Sleep deprivationBehavioural
Sleep deprivation during first night of sleep laboratory examination
| Study group | Role | What they receive |
|---|---|---|
| Baseline recording | No intervention | Not described |
| Sleep restriction | Experimental | Not described Receives: Behavioral: Sleep restriction |
| Sleep deprivation | Experimental | Not described Receives: Behavioral: Sleep deprivation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endogenous melatonin
Dim light melatonin onset (DLMO) will show whether there is a phase difference between patient groups and between patients and controls. The amplitude of the melatonin profile will show whether there is a dampening of the circadian rhythm or not.
Measured: Half an hour before and half an hour after a nap during PNP protocol, up to 2 minutes.
EEG slow-wave activity (SWA)
SWA is a marker of homeostatic sleep pressure and will show whether patients with narcolepsy or idiopathic hypersomnia live under different sleep pressure than controls.
Measured: Over nap times, up to 80 minutes.
Secondary outcomes (2)
Performance in neurobehavioral tests
Outcome for vigilance and cognition of the subjects.
Measured: One hour before each nap, up to 45mins.
EEG event related potentials (ERPs)
Measured: One hour before each nap, up to 45minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2017
- Study start28 Nov 2017
- Primary completion31 May 2019
- Study completion31 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Narcolepsy 1Studies of the same condition, open and under way.
- 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
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esther Werth
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Esther Werth, University of Zurich
- Investigators
- Esther Werth, PhD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03356938
- Sponsor's protocol ID
- CHPNP2016
- Acronym
- PNP
- Status last verified
- Feb 2021
- First submitted
- 15 Nov 2017
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borbely AA. A two process model of sleep regulation. Hum Neurobiol. 1982;1(3):195-204. No abstract available.
PubMed 7185792Dauvilliers Y, Arnulf I, Mignot E. Narcolepsy with cataplexy. Lancet. 2007 Feb 10;369(9560):499-511. doi: 10.1016/S0140-6736(07)60237-2.
PubMed 17292770Frenette E, Kushida CA. Primary hypersomnias of central origin. Semin Neurol. 2009 Sep;29(4):354-67. doi: 10.1055/s-0029-1237114. Epub 2009 Sep 9.
PubMed 19742411Munch M, Knoblauch V, Blatter K, Schroder C, Schnitzler C, Krauchi K, Wirz-Justice A, Cajochen C. Age-related attenuation of the evening circadian arousal signal in humans. Neurobiol Aging. 2005 Oct;26(9):1307-19. doi: 10.1016/j.neurobiolaging.2005.03.004. Epub 2005 Apr 18.
PubMed 16182904Saper CB, Scammell TE, Lu J. Hypothalamic regulation of sleep and circadian rhythms. Nature. 2005 Oct 27;437(7063):1257-63. doi: 10.1038/nature04284.
PubMed 16251950Wulff K, Gatti S, Wettstein JG, Foster RG. Sleep and circadian rhythm disruption in psychiatric and neurodegenerative disease. Nat Rev Neurosci. 2010 Aug;11(8):589-99. doi: 10.1038/nrn2868. Epub 2010 Jul 14.
PubMed 20631712Morgenthaler T, Alessi C, Friedman L, Owens J, Kapur V, Boehlecke B, Brown T, Chesson A Jr, Coleman J, Lee-Chiong T, Pancer J, Swick TJ; Standards of Practice Committee; American Academy of Sleep Medicine. Practice parameters for the use of actigraphy in the assessment of sleep and sleep disorders: an update for 2007. Sleep. 2007 Apr;30(4):519-29. doi: 10.1093/sleep/30.4.519.
PubMed 17520797Ryser F, Gassert R, Werth E, Lambercy O. A novel method to increase specificity of sleep-wake classifiers based on wrist-worn actigraphy. Chronobiol Int. 2023 May;40(5):557-568. doi: 10.1080/07420528.2023.2188096. Epub 2023 Mar 20.
PubMed 36938627
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of the Circadian System in Neurological Sleep-wake Disorders: Assessment of Circadian and Homeostatic Sleep-wake Regulation and Vigilance With a Poly-nap Protocol
- ClinicalTrials.gov ID
- NCT03356938
- Acronym / sponsor ID
- PNP / CHPNP2016
- Conditions
- Narcolepsy 1, Idiopathic Hypersomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Esther WerthUniversity, hospital or other
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2020 (actual)
- First posted
- 29 Nov 2017 (actual)
- 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.
The aim of this study is to investigate the role of the circadian system in patients with neurologic sleep-wake disorders. Therefore, overnight sleep will be distributed over 30 hours into repetitive sleep-wake cycles (poly-nap protocol), so that sleep episodes occur at different circadian phases. Vigilance, attention, risk behavior as well as sleep onset latency will be observed.
Ambulatory accelerometer recordings gain more and more attention in the diagnostic work-up of sleep disorders, as they allow to also include the everyday rest-activity rhythm before examinations in the sleep laboratory. Advances of novel devices should improve the detection of rest and activity and therefore the estimation of sleep and wake, especially in patients with neurologic sleep-wake disorders exhibiting fragmented sleep. Two types of actimeters will be applied throughout our study protocol to explore better classification of sleep and wake phases and patterns of the rest-activity rhythm.
This study is designed as an observational case-controlled study targeting the disorders of narcolepsy type 1 and idiopathic hypersomnia, and including interventional procedures in the healthy control group (sleep deprivation, sleep restriction) in a counter-balanced design.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Baseline recording | No intervention | – |
| Sleep restriction | Experimental | Behavioral: Sleep restriction |
| Sleep deprivation | Experimental | Behavioral: Sleep deprivation |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and Female participants 18 years to 35 years of age
- Written informed consent by the participant after information about the research project
- Healthy controls: 7-8 hours of sleep per night
- Healthy controls: sleep satiation before start of the study
- Narcolepsy type 1: diagnosis of narcolepsy with cataplexy, drug free during study, proven excessive daytime sleepiness with increased REM (MSLT), clear-cut cataplexy present, undetectable or low cerebrospinal fluid hypocretin levels (if data is available)
Key exclusion criteria (7 listed)
- signs of neurological, psychiatric, or other sleep-wake disorders
- signs of sleep deprivation
- shift work and time zone change of more than one hour within one month prior the study start
- extreme morning and evening types
- underweight
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 |
|---|---|---|
| Sleep restrictionRestricted sleep to 5 hours / night for 5 days prior to sleep laboratory examination | Behavioural | Sleep restriction |
| Sleep deprivationSleep deprivation during first night of sleep laboratory examination | Behavioural | Sleep deprivation |
Primary outcome
Endogenous melatonin
Time frame: Half an hour before and half an hour after a nap during PNP protocol, up to 2 minutes.
Dim light melatonin onset (DLMO) will show whether there is a phase difference between patient groups and between patients and controls. The amplitude of the melatonin profile will show whether there is a dampening of the circadian rhythm or not.
EEG slow-wave activity (SWA)
Time frame: Over nap times, up to 80 minutes.
SWA is a marker of homeostatic sleep pressure and will show whether patients with narcolepsy or idiopathic hypersomnia live under different sleep pressure than controls.
2 secondary outcomes
Performance in neurobehavioral tests
Time frame: One hour before each nap, up to 45mins.
EEG event related potentials (ERPs)
Time frame: One hour before each nap, up to 45minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 7185792Borbely AA. A two process model of sleep regulation. Hum Neurobiol. 1982;1(3):195-204. No abstract available.
- Background: PubMed 17292770Dauvilliers Y, Arnulf I, Mignot E. Narcolepsy with cataplexy. Lancet. 2007 Feb 10;369(9560):499-511. doi: 10.1016/S0140-6736(07)60237-2.
- Background: PubMed 19742411Frenette E, Kushida CA. Primary hypersomnias of central origin. Semin Neurol. 2009 Sep;29(4):354-67. doi: 10.1055/s-0029-1237114. Epub 2009 Sep 9.
- Background: PubMed 16182904Munch M, Knoblauch V, Blatter K, Schroder C, Schnitzler C, Krauchi K, Wirz-Justice A, Cajochen C. Age-related attenuation of the evening circadian arousal signal in humans. Neurobiol Aging. 2005 Oct;26(9):1307-19. doi: 10.1016/j.neurobiolaging.2005.03.004. Epub 2005 Apr 18.
- Background: PubMed 16251950Saper CB, Scammell TE, Lu J. Hypothalamic regulation of sleep and circadian rhythms. Nature. 2005 Oct 27;437(7063):1257-63. doi: 10.1038/nature04284.
- Background: PubMed 20631712Wulff K, Gatti S, Wettstein JG, Foster RG. Sleep and circadian rhythm disruption in psychiatric and neurodegenerative disease. Nat Rev Neurosci. 2010 Aug;11(8):589-99. doi: 10.1038/nrn2868. Epub 2010 Jul 14.
- Background: PubMed 17520797Morgenthaler T, Alessi C, Friedman L, Owens J, Kapur V, Boehlecke B, Brown T, Chesson A Jr, Coleman J, Lee-Chiong T, Pancer J, Swick TJ; Standards of Practice Committee; American Academy of Sleep Medicine. Practice parameters for the use of actigraphy in the assessment of sleep and sleep disorders: an update for 2007. Sleep. 2007 Apr;30(4):519-29. doi: 10.1093/sleep/30.4.519.
- Derived from this study: PubMed 36938627Ryser F, Gassert R, Werth E, Lambercy O. A novel method to increase specificity of sleep-wake classifiers based on wrist-worn actigraphy. Chronobiol Int. 2023 May;40(5):557-568. doi: 10.1080/07420528.2023.2188096. Epub 2023 Mar 20.
- Individual participant dataSharing planned: No
Related trials for Narcolepsy 1
RecruitingPhase 2/3
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Idiopathic Hypersomnia, Narcolepsy Type 1
RecruitingPhase 2/3
A Study to Investigate the Effects of Cleminorexton Compared With Placebo in the Treatment of Participants With Central Disorders of Hypersomnolence
Narcolepsy Type 1, Narcolepsy Type 2
Active, not recruitingObservational study
Epidemiology of Narcolepsy Type 1 and Type 2 in Spain
Narcolepsy Type 1, Narcolepsy Type 2
Active, not recruitingPhase 3
A Trial of TAK-861 for the Treatment of Narcolepsy With Cataplexy
Narcolepsy Type 1 (NT1), Narcolepsy With Cataplexy
Not yet recruitingObservational study
A Study About Treatment Use in Adults With Narcolepsy Type 1 (NT1) in Europe and Canada
Narcolepsy Type 1
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.
Esther Werth, PhD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep restriction and Sleep deprivation in people with Narcolepsy 1 and Idiopathic Hypersomnia, run by Esther Werth at 1 site in Switzerland.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 21 Feb 2021. 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 Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Endogenous melatonin (time frame: Half an hour before and half an hour after a nap during PNP protocol, up to 2 minutes.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03356938, which also lists 8 linked publications.
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 21 Feb 2021; AzTrials last refreshed its copy on 8 Nov 2026.