Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06100185
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-07-28
Brief Title:
Wearable tES for Insomnia
Sponsor:
Uniformed Services University of the Health Sciences
Organization:
Uniformed Services University of the Health Sciences
Study Overview
Official Title:
Wearable Neurotechnology for Treatment of Insomnia tES
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the ability of a translational device Teledyne PeakSleep to reduce sleep onset latency reduce time awake after sleep onset and improve restfulness and the subjective benefits of sleep in a patient population with insomnia via transcranial direct current stimulation tDCS applied to frontal lobe circuits
Detailed Description:
The purpose of this research study is to investigate a new targeted intervention to improve outcomes for those suffering from insomnia by attempting to enhance the brain rhythms within the frontal lobe implicated in slow wave generation during the transition from wake to sleep The device applies a pulsed trapezoidal direct current waveform at 075 Hz to the frontal areas of the brain immediately prior to attempted sleep onset to facilitate the transition to sleep
During this cross-over trial patients will be asked to use a PeakSleep wearable neurotechnology prototype headband which delivers 14 minutes of frontal tDCS over a 30-minute period immediately before trying to fall asleep Using an active stimulation versus sham paradigm we will compare actigraphy data physiological data and subjective sleep measures against a pre-treatment baseline in the same patient
Participants will complete five in-person visits over the course of the 8-week study The first visit includes the collection of baseline self-reported data and actigraphy device training All subsequent visits involve headset training downloading PeakSleep and actigraphy data repeating self-reported data measures and reporting user experience with the device Participants will not perform any formal sleep study visits and instead provide daily actigraphy data via a FitBit and EEG data when wearing PeakSleep in their own home
During this cross-over trial patients will be asked to use a PeakSleep wearable neurotechnology prototype headband which delivers 14 minutes of frontal tDCS over a 30-minute period immediately before trying to fall asleep Using an active stimulation versus sham paradigm we will compare actigraphy data physiological data and subjective sleep measures against a pre-treatment baseline in the same patient
Participants will complete five in-person visits over the course of the 8-week study The first visit includes the collection of baseline self-reported data and actigraphy device training All subsequent visits involve headset training downloading PeakSleep and actigraphy data repeating self-reported data measures and reporting user experience with the device Participants will not perform any formal sleep study visits and instead provide daily actigraphy data via a FitBit and EEG data when wearing PeakSleep in their own home
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None