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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Narcolepsy Type 1, Hypersomnia

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol | 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 years | 
| Specificity of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol | 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. | 2 years | 
| Positive predictive value of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol | 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. | 2 years | 
| Negative predictive value of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol | 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. | 2 years |