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

Hypersomnia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05983731
• Other study ID #: 321547
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Disorders of Excessive Somnolence
• Hypersomnia
• Narcolepsy
• Narcolepsy Type 1

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