Clinical trial NCT04445129: Wake and Sleep State Transitions on a Portable Electroencephalogram (EEG) Device in Narcolepsy Type 1 (NT1) and Healthy Participants
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy Volunteers
Narcolepsy Type 1
Lead sponsor: Takeda
Sponsor class: INDUSTRY
Collaborators: name: Takeda Development Center Americas, Inc.
First posted: 2020-06-24
Enrollment: 45
Sex: ALL
Minimum age (years): 16
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Participants, who maintain a consistent sleep-wake cycle and participants with NT1.

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.

Detailed description: This is a non-drug study including participants with NT1 and healthy participants using devices designed for at-home assessments. The study will assess whether a portable EEG device provides an EEG signal comparable to inpatient nPSG. The frequency and characteristics of wake and sleep patterns and transitions over multiple nights will also be characterized. Participants with NT1 who will complete the study TAK-994-1501 (NCT04096560) will be eligible to enter the current study following the appropriate washout period (60 days).

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.

Eligibility criteria: Inclusion Criteria:

1. Has access to at-home Wi-Fi and can add an internet-ready device with assistance.
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:

1. Has a current diagnosis of cancer except for squamous or basal cell skin cancer.
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).

Primary outcomes:
measure: Sleep State Scoring From nPSG and Portable EEG Device
timeFrame: up to 2 Nights
measure: Stage Shift Index (SSI) as Measured by Standard nPSG and EEG Device on Night 2
timeFrame: Night 2
Secondary outcomes:
measure: SSI as Measured by Standard nPSG and EEG Device During the Period at Home
timeFrame: Nights 3-7
measure: Number of Microsleeps and State Transitions During the Maintenance of Wakefulness Tests (MWTs)
timeFrame: Day 2
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford School of Medicine
state: California
city: Colorado Springs
country: United States
facility: Delta Waves Sleep Disorders and Research Center
state: Colorado
city: Clearwater
country: United States
facility: St Francis Medical Institute
state: Florida
city: Atlanta
country: United States
facility: NeuroTrials Research, Inc.
state: Georgia
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Bronx
country: United States
facility: Sleep Wake Disorders Center
state: New York
city: Denver
country: United States
facility: Research Carolina Elite, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Trial and Consulting Services
state: Ohio
city: Cincinnati
country: United States
facility: Intrepid Research
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Dublin
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
city: Columbia
country: United States
facility: Bogan Sleep Consultants, LLC
state: South Carolina
city: San Antonio
country: United States
facility: Sleep Therapy & Research Center
state: Texas
Study officials:
affiliation: Takeda Development Center Americas, Inc.
name: Medical Director
role: STUDY_DIRECTOR
References: