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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

NCT05983731 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2023-08-09

No results posted yet for this study

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.

Conditions

Sponsors & Collaborators

  • University of Surrey

    collaborator OTHER

  • Guy's and St Thomas' NHS Foundation Trust

    lead OTHER

Eligibility

Min Age
12 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-30
Primary Completion
2025-04-30
Completion
2025-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05983731 on ClinicalTrials.gov