Sleep Monitoring Device for Narcolepsy

Recruiting at 3 trial locations

Overseen By Emmanuel Mignot, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beacon Biosignals

Must not be taking: Wake promoting drugs

Disqualifiers: Stroke, Epilepsy, Sleep apnea, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

78 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study intends to examine the utility of a home-use EEG-based sleep monitor for the diagnosis and evaluation of disorders of excessive sleepiness, specifically the neurological disorder Narcolepsy Type 1.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but if you are in the Known NT1 arm, you may need to discontinue certain medications if deemed safe by the study protocol.

How does the Dreem 3S Ambulatory Sleep Monitoring Device treatment differ from other treatments for narcolepsy?

The Dreem 3S Ambulatory Sleep Monitoring Device is unique because it allows for sleep monitoring in natural settings like home and work, rather than just in a sleep lab. This can provide a more accurate picture of a patient's sleep patterns and help tailor treatments more effectively. ^{1 2 3 4 5}

Who Is on the Research Team?

Dennis Hwang, MD

Principal Investigator

Kaiser Permanente

Are You a Good Fit for This Trial?

This trial is for individuals experiencing excessive daytime sleepiness and suspect they might have Narcolepsy Type 1. Participants should be willing to use the Dreem 3S device at home to monitor their sleep.

Inclusion Criteria

Patients are able/willing to consent and willing to undergo the specified monitoring

It's safe for me to stop taking certain medications as required.

I am scheduled for a sleep test to diagnose excessive daytime sleepiness.

Exclusion Criteria

Patients deemed ineligible by the site PI or treating physician for any other reason

Shift workers or patients working unusual hours

I have had a stroke or epilepsy in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

At-home Monitoring

Participants undergo 1 week of at-home ambulatory monitoring with the Dreem Headband

1 week

No in-person visits, device used at home

In-lab Evaluation

Participants undergo formal in-lab evaluation with gold-standard polysomnography and multiple sleep latency testing while using the Dreem Headband

2 days

2 in-person visits for in-lab evaluation

Follow-up

Participants are monitored for usability and compliance with the Dreem 3S system

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Dreem 3S Ambulatory Sleep Monitoring Device

Trial Overview The study is testing the effectiveness of the Dreem 3S, a wearable EEG-based device designed for home use, in diagnosing and evaluating narcolepsy-related sleep issues.

How Is the Trial Designed?

Group I: Suspected Hypersomnia Arm [Arm A] Experimental Treatment 1 Intervention

Subjects being evaluated for a hypersomnia condition at participating sleep clinics will be recruited to Arm A. These subjects will not yet have a diagnosis and not yet be on treatment. These subjects will undergo 1 week of at-home ambulatory monitoring with the Dreem Headband, followed by formal in-lab evaluation with gold-standard polysomnography/multiple sleep latency testing while also using the Dreem Headband.

Group II: Known Narcolepsy Type 1 Arm [Arm B] Experimental Treatment 1 Intervention

Subjects with known Narcolepsy Type 1, under treatment at participating sleep clinics, will be recruited to Arm B. These subjects will be asked to withdraw from their Narcolepsy related medication therapy starting on day -7, undergo 1 week of at-home ambulatory monitoring with the Dreem Headband on days 1-7, and then undergo two consecutive nights of in-lab PSG followed by MSLT while synchronously using the Dreem headband.

Dreem 3S Ambulatory Sleep Monitoring Device is already approved in United States for the following indications:

Approved in United States as Dreem 3S for:

• Assessment of sleep on adult individuals (22 to 65 years old)
• Diagnosis and evaluation of disorders of excessive sleepiness, including Narcolepsy Type 1

Who Is Running the Clinical Trial?

Beacon Biosignals

Lead Sponsor

Trials

1

Recruited

80+

Sleep Management Institute

Collaborator

Trials

1

Recruited

80+

Kaiser Permanente

Collaborator

Trials

563

Recruited

27,400,000+

Intrepid Research

Collaborator

Trials

1

Recruited

80+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Sleep Insights

Industry Sponsor

Trials

1

Recruited

80+

Published Research Related to This Trial

In a study of 25 narcolepsy patients, despite feeling their symptoms were under control, they experienced significantly more daytime sleep (averaging 44 minutes) compared to matched control subjects (averaging 4.8 minutes).

Narcoleptic patients had shorter and more disrupted nocturnal sleep, indicating that even with satisfactory treatment, their sleep patterns were still affected, suggesting variability in disease severity and treatment responsiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of sleep and wakefulness in treated narcoleptic subjects. Rogers, AE., Aldrich, MS., Caruso, CC.[2019]

In a study of 11 narcoleptic subjects compared to 11 control subjects, sleep deprivation led to a significant decrease in total sleep time for narcoleptics, highlighting their increased sleep need.

Recovery sleep after sleep deprivation showed altered sleep architecture in narcoleptics, with increased slow-wave sleep but decreased stage 2 sleep, suggesting a disruption in the normal homeostatic regulation of sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep in human narcolepsy revisited with special reference to prior wakefulness duration. Tafti, M., Villemin, E., Carlander, B., et al.[2019]

Patients with narcolepsy-cataplexy experience significantly more daytime sleep and less nighttime sleep compared to habitual nappers, indicating a disruption in their sleep-wake patterns.

The study suggests that a decreased amplitude in the circadian arousal system may explain the earlier peak in daytime sleep propensity in narcoleptics, which could account for various symptoms associated with the disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impaired circadian waking arousal in narcolepsy-cataplexy. Broughton, R., Krupa, S., Boucher, B., et al.[2006]

Narcoleptic patients with sleep-onset REM periods (SOREMP) showed distinct patterns in their core body temperature and motor activity compared to controls, indicating a potential defect in the mechanisms that trigger REM sleep.

Both narcoleptic groups exhibited altered temperature rhythms, such as a dampened temperature amplitude and an earlier decline in temperature during sleep, suggesting a circadian rhythm disorder that may contribute to their sleep disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Circadian temperature and activity rhythms in unmedicated narcoleptic patients. Mayer, G., Hellmann, F., Leonhard, E., et al.[2019]

The American Academy of Sleep Medicine has established quality measures for narcolepsy care, focusing on reducing excessive daytime sleepiness through quantifying sleepiness and initiating treatment.

To improve diagnosis accuracy, the recommended measures include completing a comprehensive sleep history and conducting objective sleep assessments, while also emphasizing the importance of treatment follow-up and safety counseling to reduce adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality measures for the care of patients with narcolepsy. Krahn, LE., Hershner, S., Loeding, LD., et al.[2018]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Patterns of sleep and wakefulness in treated narcoleptic subjects. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Sleep in human narcolepsy revisited with special reference to prior wakefulness duration. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Impaired circadian waking arousal in narcolepsy-cataplexy. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Circadian temperature and activity rhythms in unmedicated narcoleptic patients. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Quality measures for the care of patients with narcolepsy. [2018]