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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05983731
Other study ID # 321547
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 2023
Est. completion date August 2025

Study information

Verified date August 2023
Source Guy's and St Thomas' NHS Foundation Trust
Contact Thomas Rossor, PhD
Phone +442071887188
Email thomas.rossor@gstt.nhs.uk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date August 2025
Est. primary completion date April 2025
Accepts healthy volunteers No
Gender All
Age group 12 Years to 25 Years
Eligibility 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


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust University of Surrey

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
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