Nextsense Brain-sensing Buds Study

Phase

N/A

Condition

N/A

Treatment

Deflated Sleep Data Feedback

Accurate Sleep Data Feedback + Sleep-related Educational Information

Accurate Sleep Data Feedback

Clinical Study ID

NCT06602960

Sterling IRB #12205

Ages 25-65
All Genders
Accepts Healthy Volunteers

Study 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:

Does receiving sleep-related feedback from a wearable sleep tracker affect an individual's mindset about sleep?
How does the mindset about sleep influence sleep quality, sleepiness, and stress/anxiety levels related to sleep?
Does the feedback on sleep data moderate the relationship between one's mindset about sleep and their sleep quality?

Participants will:

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.
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.
For Weeks 3-4, wear a Fitbit and Brain-Sensing earbuds, receiving daily feedback on their sleep.
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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

All participants have the capacity to understand the informed consent for studyparticipation and ability for subject to comply with the requirements of the study
Experiencing mild to moderate sleep disturbances, but without sleep disorderdiagnosis
Naïve to sleep tracker use
Age 25-65

Exclusion

Exclusion Criteria:

Participants who have used any type of sleep tracker, such as Oura, Fitbit, GoogleFit, Garmin Connect, or Apple Watch Sleep
Health conditions (i.e., cancer, cognitive impairment, panic disorder,post-traumatic stress disorder, sleep apnea, insomnia, restless leg syndrome,Parkinson's disease)
Use of Modafinil (Provigil), Methylphenidate (Ritalin), Sodium oxybate (Xyrem),Melatonin, Benadryl, Wakix, Sunosi or prescription medications for ADHD Enrollmentin other sleep studies
Women who are pregnant or who are currently nursing/breastfeeding will be excludedfrom this study.

Study Design

Deflated Sleep Data Feedback

October 07, 2024

April 15, 2025

Study 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 individuals' 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.

Connect with a study center

Alethios (Virtual Study Platform)
San Francisco, California 94109
United States
Site Not Available

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