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A Pilot Observational Study to Assess the Ability of Continuous 'Home' EEG to Accurately Diagnose Narcolepsy and Demonstrate Response to Treatment

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ClinicalTrials.gov Identifier: NCT05983731
Recruitment Status : Not yet recruiting
First Posted : August 9, 2023
Last Update Posted : August 9, 2023
Sponsor:
Collaborator:
University of Surrey
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Study Description
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Brief Summary:

The goal of this pilot observational study is to assess the ability of continuous 'home' EEG to accurately diagnose Narcolepsy in children and young people with hypersomnia. The main question[s]it aims to answer are:

  • can ambulatory home monitoring using a Dreem headband with a 'life as usual' unrestricted protocol allow accurate diagnosis of Narcolepsy, compared to gold standard in-patient PSG and MSLT
  • which EEG derived sleep parameters and study duration yield most diagnostic accuracy

Participants undergoing investigation for hypersomnia will additionally be asked to wear a Dream Headband at night for weeknights, then continuously for 48 hours over the weekend. The data from the headband will then be analysed to see if it can predict the results of the polysomnography and MSLT that form routine clinical care.


Condition or disease
Narcolepsy Type 1 Hypersomnia

Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Pilot Observational Study to Assess the Ability of Continuous 'Home' EEG to Accurately Diagnose Narcolepsy and Demonstrate Response to Treatment
Estimated Study Start Date : September 2023
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Sensitivity of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol [ Time Frame: 2 years ]
    Sensitivity (%) of Dreem headband derived EEG in predicting a final diagnosis of Narcolepsy derived from gold standard in-patient clinical testing with polysomnography and multiple sleep latency test ICSD-3 protocol.

  2. Specificity of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol [ Time Frame: 2 years ]
    Specificity (%) of Dreem headband derived EEG in predicting a final diagnosis of Narcolepsy derived from gold standard in-patient clinical testing with polysomnography and multiple sleep latency test ICSD-3 protocol.

  3. Positive predictive value of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol [ Time Frame: 2 years ]
    Positive predictive value (%) of Dreem headband derived EEG in predicting a final diagnosis of Narcolepsy derived from gold standard in-patient clinical testing with polysomnography and multiple sleep latency test ICSD-3 protocol.

  4. Negative predictive value of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol [ Time Frame: 2 years ]
    Negative predictive value (%) of Dreem headband derived EEG in predicting a final diagnosis of Narcolepsy derived from gold standard in-patient clinical testing with polysomnography and multiple sleep latency test ICSD-3 protocol.


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population will comprise children and young adults seen in the hypersomnia clinics of the LifeSpan sleep service at Guys and St Thomas' Hospital and The Evelina London Children's Hospital.
Criteria

Inclusion Criteria:

  • Participants already under investigation within GSTT children and adult sleep service for hypersomnolence
  • Age 12 to 25 years of age at recruitment
  • Participants able to understand patient information (information including DH instructions written only in English for this initial observational study) and who can provide written informed consent or assent.

Exclusion Criteria:

  • Any physician diagnosed sleep disorder (e.g. sleep apnea)
  • Any physician diagnosed medical or psychiatric disorder that could explain their excessive daytime sleepiness
  • Regular use of either prescribed or recreational medication that affects sleep
  • Participation in another concurrent research study
Contacts and Locations
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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): NCT05983731


Contacts
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Contact: Thomas Rossor, PhD +442071887188 thomas.rossor@gstt.nhs.uk
Contact: Paul Gringras paul.gringras@gstt.nhs.uk

Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
University of Surrey
More Information
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT05983731    
Other Study ID Numbers: 321547
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Narcolepsy
Disorders of Excessive Somnolence
Sleep Disorders, Intrinsic
Dyssomnias
 Sleep Wake Disorders
Nervous System Diseases
Mental Disorders