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

NCT05983731 | Unknown

• 1 other identifier: 321547
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Narcolepsy Type 1; Hypersomnia

Outcome Measures

Primary Outcomes (4)

• 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

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise children and young adults seen in the hypersomnia clinics of the LifeSpan sleep service at Guys and St Thomas' Hospital and The Evelina London Children's Hospital.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• University of Surrey: collaborator

MeSH Terms

Conditions

Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Thomas Rossor, PhD

CONTACT

+442071887188; thomas.rossor@gstt.nhs.uk

Paul Gringras

CONTACT

paul.gringras@gstt.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: August 9, 2023
• Study Start: September 1, 2023
• Primary Completion: April 1, 2025
• Study Completion: August 1, 2025
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share