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.
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.
Study Type
OBSERVATIONAL
Enrollment
45
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.
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
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.
Time frame: 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.
Time frame: Night 2
SSI as Measured by Standard nPSG and EEG Device During the Period at Home
SSI will be measured by portable EEG device on nights 3-7 at home. 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 SSI will be analyzed using the intrasubject correlation (intraclass correlation across different nights) in participants with NT1 and healthy participants. The nPSG is a standardized procedure used to assess various sleep parameters, including sleep latency and sleep architecture.
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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
...and 3 more locations
Time frame: Nights 3-7
Number of Microsleeps and State Transitions During the Maintenance of Wakefulness Tests (MWTs)
Micro sleeps are defined as appearance of any stage of sleep arising out of wakefulness lasting from 3 seconds to less than or equal to (\<=) 15 seconds and assessed on signals obtained from portable EEG device. State transition refers to switch between wake and sleep. MWT is a validated, objective measure used to measure excessive daytime somnolence (EDS) in clinical studies. MWT evaluate a person's ability to remain awake under soporific conditions for a defined period. Wakefulness will be measured indirectly by time to fall asleep using MWT. Four 40-minute trials will be administered (each 4 session 40-minute MWT is considered as complete test). Sleep onset is defined as first epoch of greater than 15 seconds of cumulative sleep in a 30-second epoch. Trials are ended after 40 minutes if no sleep occurs/after unequivocal sleep, defined as 3 consecutive epochs of stage 1 sleep or 1 epoch of any other stage of sleep. If no sleep has been observed, then latency is defined as 40 minutes.
Time frame: Day 2