Nextsense Brain-sensing Buds 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:

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.

Conditions

• Sleep
• Sleep Quality
• Sleepiness, Daytime
• Technology

Interventions

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.

Sponsors & Collaborators

• NextSense, Inc.

  lead INDUSTRY

Principal Investigators

• Kyung Mi Kim, PhD · MandK Consulting Partners

• Michele D Nelson, PhD · MandK Consulting Partners

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-10-07

Primary Completion

2025-02-05

Completion

2025-04-15

Countries

• United States

Study Locations