NCT06602960

Nextsense Brain-sensing Buds Study

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: NextSense, Inc. · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Accepted

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 individual\'s mindset about sleep? 2. How does the mindset about sleep influence sleep quality, sleepiness, and stress/anxiety levels related to sleep? 3. Does the feedback on sleep data moderate the relationship between one\'s 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 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.

Conditions

• Sleep
• Sleep Quality
• Sleepiness, Daytime
• Technology

Interventions

Type	Name	Description
BEHAVIORAL	Accurate Sleep Data Feedback	Participants will receive accurate feedback about their sleep data.
BEHAVIORAL	Inflated Sleep Data Feedback	Participants will receive inflated feedback about their sleep data, suggesting better sleep quality than detected by Fitbit (actual sleep hours +10%).
BEHAVIORAL	Deflated Sleep Data Feedback	Participants will receive deflated feedback about their sleep data, suggesting poorer sleep quality than detected by Fitbit (actual sleep hours -10%).
BEHAVIORAL	Accurate Sleep Data Feedback + Sleep-related Educational Information	Participants will receive accurate feedback about their sleep data along with sleep-related educational information.

Timeline

• Start date: 2024-10-07
• Primary completion: 2025-02-05
• Completion: 2025-04-15
• First posted: 2024-09-19
• Last updated: 2025-04-18

Locations

1 site across 1 country: United States