Wake and Sleep State Transitions on a Portable Electroencephalogram (EEG) Device in Narcolepsy Type 1 (NT1) and Healthy Participants
NCT ID: NCT04445129
Last Updated: 2021-05-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
45 participants
OBSERVATIONAL
2020-08-03
2021-05-04
Brief Summary
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Detailed Description
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The study will enroll approximately 32 participants (16 participants with NT1 and 16 healthy participants). Participants will be enrolled in the 2 groups:
* NT1 Participants
* Healthy Participants
This multi-center trial will be conducted in the United States. The overall time to participate in this study is approximately 8 days. The follow-up visit will occur on Day 10 and during this debrief, participants will answer a questionnaire on user experience (device comfort) for the wearable devices.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Portable EEG Device
Portable EEG device is lightweight and designed for nighttime wear.
Portable ECG Device
Portable ECG device is waterproof and will be adhered to the chest of the participant.
Accelerometry
Portable accelerometry device is noninvasive and will capture data on participant activity level, including intensity of movement, rest, and sleep.
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.
Portable EEG Device
Portable EEG device is lightweight and designed for nighttime wear.
Portable ECG Device
Portable ECG device is waterproof and will be adhered to the chest of the participant.
Accelerometry
Portable accelerometry device is noninvasive and will capture data on participant activity level, including intensity of movement, rest, and sleep.
Interventions
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Portable EEG Device
Portable EEG device is lightweight and designed for nighttime wear.
Portable ECG Device
Portable ECG device is waterproof and will be adhered to the chest of the participant.
Accelerometry
Portable accelerometry device is noninvasive and will capture data on participant activity level, including intensity of movement, rest, and sleep.
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. 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).
4. Must not require use of sleep aids or must be willing to discontinue use of sleep aids for the duration of the study.
5. 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:
1. With NT1 who is drug-naïve may also be enrolled.
2. With NT1 must present with subjective sleep complaint.
3. With NT1 must have a diagnosis of NT1, as defined by the International Classification of Sleep Disorders, 3rd edition (ICSD-3) criteria.
Exclusion Criteria
2. 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.
3. 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).
4. Undergoing current treatment for hepatitis B with interferon.
5. 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.
6. 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.
7. Has a lifetime history of major psychiatric disorder, such as bipolar disorder or schizophrenia.
8. 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.
9. Has a medical disorder (other than narcolepsy), associated with excessive daytime sleepiness. This includes clinically significant obstructive sleep apnea or other sleep disturbances that has a significant impact on daytime sleepiness, confirmed by past PSG data (example, apnea hypopnea index \>=10, periodic limb movement disorder index in sleep \>=15) or a periodic limb movement disorder arousal index of \>=10, or as evaluated on interview at the screening visit. Because nPSG data is obtained on Day 1, participants may be removed from study if they meet the above exclusion at the discretion of the principal investigator. Participants removed under this criterion will be replaced.
10. At the time of screening the participant is being treated with nasal or oro-nasal positive airway pressure for any reason.
11. Is currently being prescribed sodium oxybate or has been off of sodium oxybate for less than 4 weeks.
12. Is using varenicline (Chantix).
16 Years
60 Years
ALL
Yes
Sponsors
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Takeda Development Center Americas, Inc.
INDUSTRY
Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Takeda Development Center Americas, Inc.
Locations
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Stanford School of Medicine
Redwood City, California, United States
Delta Waves Sleep Disorders and Research Center
Colorado Springs, Colorado, United States
St Francis Medical Institute
Clearwater, Florida, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Sleep Wake Disorders Center
The Bronx, New York, United States
Research Carolina Elite, LLC
Denver, North Carolina, United States
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, United States
Intrepid Research
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio Sleep Medicine Institute
Dublin, Ohio, United States
Bogan Sleep Consultants, LLC
Columbia, South Carolina, United States
Sleep Therapy & Research Center
San Antonio, Texas, United States
Countries
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Other Identifiers
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U1111-1251-7993
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-994-0001
Identifier Type: -
Identifier Source: org_study_id
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