Clinical trial NCT06602960: Nextsense Brain-sensing Buds Study
Official title: Nextsense Brain-sensing Buds Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sleep
Sleep Quality
Sleepiness, Daytime
Technology
Keywords: sleep
mindset about sleep
brain-sensing buds
Lead sponsor: NextSense, Inc.
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 individual\&#39;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\&#39;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\&#39; 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Participant-reported Sleep Quality
timeFrame: 4 weeks (Week 1 - Week 4): measured at baseline, in daily surveys.
measure: Sleep data - Total hours of sleep
timeFrame: 2 weeks (Week 3 - Week 4): measured daily, sleep data tracked by Fitbit will be transmitted to the Alethios platform automatically once a day.
measure: Modified Karolinska Sleepiness Scale
timeFrame: 4 weeks (Week 1 - Week 4): measured at baseline, in daily surveys.
measure: Fitbit tracked Sleep Quality
timeFrame: 2 weeks (Week 3 - Week 4): measured daily, sleep data tracked by Fitbit will be transmitted to the Alethios platform automatically once a day.
Secondary outcomes:
measure: Anxiety, Stress, and Mindset related to Sleep
timeFrame: 4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.
measure: Dysfunctional Beliefs and Attitudes about Sleep 16-item
timeFrame: 4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.
measure: Modified Insomnia Severity Index
timeFrame: Week 2 and Week 4: measured twice.
measure: Satisfaction with sleep
timeFrame: Week 2 and Week 4: measured twice.
measure: Sleep Problems Interference with Daily Functioning
timeFrame: Week 2 and Week 4: measured twice.
measure: Pre-Sleep Arousal Scale
timeFrame: 4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.
Other outcomes:
measure: Virtual Research Participation
timeFrame: Once at the end of the study, through study completion, which averages approximately 1 year.
Locations:
city: San Francisco
country: United States
facility: Alethios (Virtual Study Platform)
state: California
Study officials:
affiliation: MandK Consulting Partners
name: Kyung Mi Kim, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MandK Consulting Partners
name: Michele D Nelson, PhD
role: PRINCIPAL_INVESTIGATOR
References: