Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06602960
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Nextsense Brain-sensing Buds Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Nextsense Brain-sensing Buds Study
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this clinical trial is to explore how the presentation of sleep data impacts sleep quality sleep-related behaviors such as sleepiness and sleep-related anxiety and stress The study aims to answer the following key questions
1 Does receiving sleep-related feedback from a wearable sleep tracker affect an individual39s mindset about sleep
2 How does the mindset about sleep influence sleep quality sleepiness and stressanxiety levels related to sleep
3 Does the feedback on sleep data moderate the relationship between one39s mindset about sleep and their sleep quality
Participants will
1 Be randomly assigned to receive different types of feedback about their sleep data to determine if the way sleep data is presented influences self-reported sleep quality sleepiness and sleep-related stress
2 During the baseline period Weeks 1-2 complete daily and weekly surveys assessing their sleep habits beliefs about sleep anxiety stress and mindset regarding sleep
3 For Weeks 3-4 wear a Fitbit and Brain-Sensing earbuds receiving daily feedback on their sleep
4 At the end of the study provide feedback on their experience using the devices Participants may choose to return the devices or keep them after the study concludes
1 Does receiving sleep-related feedback from a wearable sleep tracker affect an individual39s mindset about sleep
2 How does the mindset about sleep influence sleep quality sleepiness and stressanxiety levels related to sleep
3 Does the feedback on sleep data moderate the relationship between one39s mindset about sleep and their sleep quality
Participants will
1 Be randomly assigned to receive different types of feedback about their sleep data to determine if the way sleep data is presented influences self-reported sleep quality sleepiness and sleep-related stress
2 During the baseline period Weeks 1-2 complete daily and weekly surveys assessing their sleep habits beliefs about sleep anxiety stress and mindset regarding sleep
3 For Weeks 3-4 wear a Fitbit and Brain-Sensing earbuds receiving daily feedback on their sleep
4 At the end of the study provide feedback on their experience using the devices Participants may choose to return the devices or keep them after the study concludes
Detailed Description:
With the growing prevalence of sleep-tracking wearables available to consumers understanding the psychological and behavioral impacts they have on users is important Recent advancements in wearable technology allow for monitoring various sleep parameters providing users with extensive data on their sleep patterns The study aims to examine how the presentation of sleep data influences user sleep quality sleep-related behaviors including sleepiness and sleep-related anxiety and stress It will evaluate how the presentation of sleep data affects individuals39 perceptions of sleep and related health issues including daytime sleepiness and perceived sleep quality Participants will receive sleep data feedback based on new methods assessed using Fitbit brain-sensing earbuds and other factors that might impact sleep Additionally the study seeks to offer valuable insights into sleep research behavioral psychology and wearable technology
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None