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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1251-7993 | Registry Identifier | WHO |
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| Name | Class |
|---|---|
| Takeda Development Center Americas, Inc. | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Portable EEG Device | Device | Portable EEG device is lightweight and designed for nighttime wear. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Participants With NT1 Only:
Exclusion Criteria:
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Healthy Participants, who maintain a consistent sleep-wake cycle and participants with NT1.
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Takeda Development Center Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford School of Medicine | Redwood City | California | 94063 | United States | ||
| Delta Waves Sleep Disorders and Research Center |
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.
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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.
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| Portable ECG Device | Device | Portable ECG device is waterproof and will be adhered to the chest of the participant. |
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| Accelerometry | Device | Portable accelerometry device is noninvasive and will capture data on participant activity level, including intensity of movement, rest, and sleep. |
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| 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. | Day 2 |
| 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 |
| ID | Term |
|---|---|
| D061725 | Accelerometry |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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