Nextsense Brain-sensing Buds Study

Stopped early · Not applicable

Conditions studied: Sleep, Sleep Quality, Sleepiness, Daytime, Technology

In brief

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.

Key facts

Study ID

NCT06602960

Run by

NextSense, Inc.

People needed

40

Starts

2024-10-07

Expected to finish

2025-04-15

Last updated by the study team

2025-04-18

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• Participants who have used any type of sleep tracker, such as Oura, Fitbit, Google Fit, 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 Enrollment in other sleep studies
• Women who are pregnant or who are currently nursing/breastfeeding will be excluded from this study.

Where it is running

• Alethios (Virtual Study Platform) — San Francisco, California, United States

Full record on ClinicalTrials.gov

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