Wake and Sleep State Transitions on a Portable Electroencephalogram (EEG) Device in Narcolepsy Type 1 (NT1) and Healthy Participants
A Study to Assess the Frequency and Characteristics of Wake and Sleep State Transitions Over Multiple Nights in Subjects With Narcolepsy Type 1 Compared With Healthy Subjects Using a Portable Electroencephalogram Device
2 other identifiers
observational
45
1 country
13
Brief Summary
The purpose of this study is to determine whether portable devices can provide measurements at home similar to those taken in the clinic, in particular in participant with NT1, and to investigate night-to-night changes in sleep patterns using these devices at home. This study may enable future at-home studies and ultimately lead to a decreased burden on the people who need these measurements.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2020
Shorter than P25 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2020
CompletedFirst Posted
Study publicly available on registry
June 24, 2020
CompletedStudy Start
First participant enrolled
August 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 4, 2021
CompletedMay 7, 2021
May 1, 2021
9 months
June 22, 2020
May 6, 2021
Conditions
Outcome Measures
Primary Outcomes (2)
Sleep State Scoring From nPSG and Portable EEG Device
The concordance between EEG signals obtained from the portable EEG device with nPSG over 2 inpatient night stays will be assessed using data obtained during the inpatient setting from nPSG and a portable EEG device. Scoring of sleep stages occur in 30-seconds epoch based on American Academy of Sleep Medicine (AASM) scoring rules. The output from the nPSG and the portable EEG device will be hand scored for each participant, with the rater assigning 1 of 5 sleep/wake stages to each 30 second epoch 3 stages of non-REM (NREM) sleep (N1, N2, N3), rapid eye movement (REM), and wakefulness (W). The nPSG is a standardized procedure used to assess various sleep parameters, including sleep latency and sleep architecture. nPSG will be used to as the comparator to the portable EEG device.
up to 2 Nights
Stage Shift Index (SSI) as Measured by Standard nPSG and EEG Device on Night 2
SSI will be measured by standard nPSG and portable EEG device on Night 2 in the clinic. SSI will be calculated as the number of transitions between any wake or sleep stage divided by hours of total sleep time. The summary of the frequency of different stages of sleep transitions can be represented by SSI, which can be used to differentiate healthy participant from those with sleep pathology. The correlation between the SSI as measured by the portable EEG device and by the nPSG will be analyzed for participants with NT1 and healthy controls. The nPSG is a standardized procedure used to assess various sleep parameters, including sleep latency and sleep architecture. nPSG will be used as the comparator to the portable EEG device.
Night 2
Secondary Outcomes (2)
SSI as Measured by Standard nPSG and EEG Device During the Period at Home
Nights 3-7
Number of Microsleeps and State Transitions During the Maintenance of Wakefulness Tests (MWTs)
Day 2
Study Arms (2)
Narcolepsy Type 1 Participants
Participants with NT1 on stable wake-promoting medications and exclusive of any sleep promoting medications will be fitted with the portable electrocardiogram (ECG) device combined with wrist accelerometry and undergo a 2-night nPSG combined with the portable EEG device.
Healthy Participants
Participants who are healthy sex- and age (plus or minus 5 years)-matched controls will be fitted with the portable ECG device combined with wrist accelerometry and undergo a 2-night nPSG combined with the portable EEG device.
Interventions
Portable EEG device is lightweight and designed for nighttime wear.
Portable ECG device is waterproof and will be adhered to the chest of the participant.
Portable accelerometry device is noninvasive and will capture data on participant activity level, including intensity of movement, rest, and sleep.
Eligibility Criteria
Healthy Participants, who maintain a consistent sleep-wake cycle and participants with NT1.
You may qualify if:
- Has access to at-home Wi-Fi and can add an internet-ready device with assistance.
- Body mass index (BMI) between greater than equal to (\>=) 18.0 and less than or equal to (\<=) 40.0 kilogram per square meter (kg/m\^2) at the screening visit.
- Must have regular sleep-wake habits (example, routinely spending 6.5 to 8.5 hours sleeping nightly, not oversleeping by more than 2 hours on weekends, that is, total sleep not more than approximately 10.5 hours) as determined by investigator interviews and confirmed in accelerometry/actigraphy records obtained between screening and first visit (measured using a minimum of 10 day/night consecutive periods) and who regularly fall asleep between 9:30 PM and 12:00 AM (healthy participants only).
- Must not require use of sleep aids or must be willing to discontinue use of sleep aids for the duration of the study.
- Has completed the TAK-994-1501 study, the participant is eligible to enter the current study following the appropriate washout period (60 days).
- Participants With NT1 Only:
- With NT1 who is drug-naïve may also be enrolled.
- With NT1 must present with subjective sleep complaint.
- With NT1 must have a diagnosis of NT1, as defined by the International Classification of Sleep Disorders, 3rd edition (ICSD-3) criteria.
You may not qualify if:
- Has a current diagnosis of cancer except for squamous or basal cell skin cancer.
- Has a nicotine or marijuana dependence that is likely to have an effect on sleep (example, a participant who routinely awakens at night to smoke) and/or an unwillingness to discontinue all smoking and nicotine use during the confinement portions of the study.
- Cannot maintain stable sleep environment at home, for example, due to young children not yet sleeping through the night or partners with disrupted sleep (example, shift workers).
- Undergoing current treatment for hepatitis B with interferon.
- Has a risk of suicide according to endorsement of Item 4 or 5 of the screening visit Columbia Suicide Severity Rating Scale (C-SSRS) or has made a suicide attempt in the previous 6 months.
- Has medical condition, such as past or current epilepsy, seizure, head injury/trauma, medically significant unstable cardiovascular, pulmonary, hepatic, renal, or gastrointestinal disease, that interferes with a normal sleep pattern or would preclude enrollment in the view of the investigator.
- Has a lifetime history of major psychiatric disorder, such as bipolar disorder or schizophrenia.
- As of the screening visit and throughout the study, the participant should not be a chronic caffeine user, as defined by an excessive (greater than \[\>\] 600 milligram \[mg\]/day) caffeine intake per day.
- At the time of screening the participant is being treated with nasal or oro-nasal positive airway pressure for any reason.
- Is currently being prescribed sodium oxybate or has been off of sodium oxybate for less than 4 weeks.
- Is using varenicline (Chantix).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
- Takeda Development Center Americas, Inc.collaborator
Study Sites (13)
Stanford School of Medicine
Redwood City, California, 94063, United States
Delta Waves Sleep Disorders and Research Center
Colorado Springs, Colorado, 80918, United States
St Francis Medical Institute
Clearwater, Florida, 33765, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, 30328, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804, United States
Sleep Wake Disorders Center
The Bronx, New York, 10467, United States
Research Carolina Elite, LLC
Denver, North Carolina, 28037, United States
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, 45212, United States
Intrepid Research
Cincinnati, Ohio, 45245, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017, United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201, United States
Sleep Therapy & Research Center
San Antonio, Texas, 78229, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Takeda Development Center Americas, Inc.
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 22, 2020
First Posted
June 24, 2020
Study Start
August 3, 2020
Primary Completion
April 29, 2021
Study Completion
May 4, 2021
Last Updated
May 7, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.