Healthy VolunteersNCT04445129

Wake and Sleep State Transitions on a Portable Electroencephalogram (EEG) Device in Narcolepsy Type 1 (NT1) and Healthy Participants

An observational study of Healthy Volunteers and Narcolepsy Type 1, run by Takeda at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 16 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers, Narcolepsy Type 1
What is being tested?: Portable EEG Device, Portable ECG Device and Accelerometry
Type of treatment: Medical device
How many people: 45 participants
Where: 13 sitesUnited States
Study dates: 3 Aug 2020to 4 May 2021
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 60 years
All sexes
Healthy volunteers accepted
Child, Adult

Study population: Healthy Participants, who maintain a consistent sleep-wake cycle and participants with NT1.

Who may be able to join

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:

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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.

Who cannot join

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.

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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.
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.
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).

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

NeuroTrials Research, Inc.
Atlanta, Georgia, 30328
CTI Clinical Trial and Consulting Services
Cincinnati, Ohio, 45212
Intrepid Research
Cincinnati, Ohio, 45245
St Francis Medical Institute
Clearwater, Florida, 33765
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Delta Waves Sleep Disorders and Research Center
Colorado Springs, Colorado, 80918
Bogan Sleep Consultants, LLC
Columbia, South Carolina, 29201
Research Carolina Elite, LLC
Denver, North Carolina, 28037
Ohio Sleep Medicine Institute
Dublin, Ohio, 43017
Fort Wayne Neurological Center
Fort Wayne, Indiana, 46804
Stanford School of Medicine
Redwood City, California, 94063
Sleep Therapy & Research Center
San Antonio, Texas, 78229
Sleep Wake Disorders Center
The Bronx, New York, 10467

Other trials in United States

About this study

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

Read the 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.

Conditions: Healthy Volunteers, Narcolepsy Type 1
Being tested: Portable EEG Device, Portable ECG Device, Accelerometry

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Portable EEG DeviceDevice
Portable EEG device is lightweight and designed for nighttime wear.
Portable ECG DeviceDevice
Portable ECG device is waterproof and will be adhered to the chest of the participant.
AccelerometryDevice
Portable accelerometry device is noninvasive and will capture data on participant activity level, including intensity of movement, rest, and sleep.

Study groups in NCT04445129
Study group	Role	What they receive
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. Receives: Device: Portable EEG Device; Device: Portable ECG Device; Device: Accelerometry
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. Receives: Device: Portable EEG Device; Device: Portable ECG Device; Device: Accelerometry

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Night 2

Secondary outcomes (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.
Measured: 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.
Measured: Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Aug 20204 May 2021

First posted24 Jun 2020
Study start3 Aug 2020
Primary completion29 Apr 2021
Study completion4 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
More trials run by TakedaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04445129
Sponsor's protocol ID: TAK-994-0001
Other IDs: U1111-1251-7993
Status last verified: May 2021
First submitted: 22 Jun 2020
Last updated: 7 May 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04445129
Acronym / sponsor ID: TAK-994-0001
Conditions: Healthy Volunteers, Narcolepsy Type 1
Study type: Observational
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Collaborators: Takeda Development Center Americas, Inc.
Study start: 3 Aug 2020 (actual)
Primary completion: 29 Apr 2021 (actual)
Study completion: 4 May 2021 (actual)
First posted: 24 Jun 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Narcolepsy Type 1 Participants	–	Device: Portable EEG Device, Device: Portable ECG Device, Device: AccelerometryParticipants 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	–	Device: Portable EEG Device, Device: Portable ECG Device, Device: AccelerometryParticipants 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.

Who may qualify

Ages: 16 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult
Study population: Healthy Participants, who maintain a consistent sleep-wake cycle and participants with NT1.

Key inclusion criteria (9 listed)

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).

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Portable EEG DevicePortable EEG device is lightweight and designed for nighttime wear.	Device	Healthy Participants, Narcolepsy Type 1 Participants
Portable ECG DevicePortable ECG device is waterproof and will be adhered to the chest of the participant.	Device	Healthy Participants, Narcolepsy Type 1 Participants
AccelerometryPortable accelerometry device is noninvasive and will capture data on participant activity level, including intensity of movement, rest, and sleep.	Device	Healthy Participants, Narcolepsy Type 1 Participants

Primary outcome

Sleep State Scoring From nPSG and Portable EEG Device
Time frame: up to 2 Nights
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.
Stage Shift Index (SSI) as Measured by Standard nPSG and EEG Device on Night 2
Time frame: 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.

2 secondary outcomes

SSI as Measured by Standard nPSG and EEG Device During the Period at Home
Time frame: Nights 3-7
Number of Microsleeps and State Transitions During the Maintenance of Wakefulness Tests (MWTs)
Time frame: Day 2

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
Individual participant dataSharing planned: Yes. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Director study director

Takeda Development Center Americas, Inc.

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Volunteers and Narcolepsy Type 1, run by Takeda at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep State Scoring From nPSG and Portable EEG Device (time frame: up to 2 Nights). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04445129.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.