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

Not yet recruiting

• Conditions: Narcolepsy Type 1; Hypersomnia

• Registration Number: NCT05983731
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-17
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-07
• Last Update Submitted: 2023-08-07
• Study First Posted: 2023-08-09
• Last Update Posted: 2023-08-09
• Study Start: 2023-09
• Primary Completion: 2025-04
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol	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.
Negative predictive value of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol	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.
Positive predictive value of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol	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.
Specificity of diagnosis of Narcolepsy Type 1 derived by Dreem Headband compared to standard ICSD-3 protocol	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.