Nextsense Brain-sensing Buds Study

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.

Study Overview

• Status: Terminated
• Conditions: Sleep; Sleep Quality; Technology; Sleepiness, Daytime
• Intervention / Treatment: Behavioral: Accurate Sleep Data Feedback; Behavioral: Inflated Sleep Data Feedback; Behavioral: Deflated Sleep Data Feedback; Behavioral: Accurate Sleep Data Feedback + Sleep-related Educational Information

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94109
      • Alethios (Virtual Study Platform)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Group; All arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey. In this arm, participants will receive accurate feedback about their sleep data.	Behavioral: Accurate Sleep Data Feedback; Participants will receive accurate feedback about their sleep data.
Experimental: Intervention Group 1; All arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey. In this arm, participants will receive inflated feedback about their sleep data, suggesting better sleep quality than detected by Fitbit (actual sleep hours +10%).	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%).
Experimental: Intervention Group 2; All arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey. In this arm, participants will receive deflated feedback about their sleep data, suggesting poorer 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%).
Experimental: Intervention Group 3; All arms receive identical instructions during the onboarding session, which includes information about the study's purpose and the use of Fitbit and NextSense brain-sensing earbuds. Participants are provided with a Fitbit and NextSense brain-sensing earbuds upon enrollment in the study and are instructed to wear them during weeks 3-4. Throughout the 4 weeks, participants complete short daily surveys and longer weekly surveys. At the end of the study, participants complete an "offboarding" survey. In this arm, participants will receive accurate feedback about their sleep data along with sleep-related educational information.	Behavioral: Accurate Sleep Data Feedback + Sleep-related Educational Information; Participants will receive accurate feedback about their sleep data along with sleep-related educational information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant-reported Sleep Quality	Measured via self-report using the 15-item Groningen Sleep Quality Scale, with scores ranging from 1 to 14. A score of 14 indicates poor sleep quality the previous night.	4 weeks (Week 1 - Week 4): measured at baseline, in daily surveys.
Sleep data - Total hours of sleep	Total hours of sleep data tracked by Fitbit	2 weeks (Week 3 - Week 4): measured daily, sleep data tracked by Fitbit will be transmitted to the Alethios platform automatically once a day.
Modified Karolinska Sleepiness Scale	Sleepiness, measured via self-report using the 1-item modified Karolinska Sleepiness Scale, ranges from 1 to 10, with 1 indicating extreme alertness, 3 alert, 5 neither alert nor sleepy, 7 sleepy but no difficulty remaining awake, 9 extremely sleepy, fighting sleep, and 10 extremely sleepy, falling asleep all the time.	4 weeks (Week 1 - Week 4): measured at baseline, in daily surveys.
Fitbit tracked Sleep Quality	Fitbit sleep score, ranging from 0 to 100, indicates sleep quality: 90-100 is excellent, 80-89 good, 60-79 fair, and 0-59 poor, based on duration, disturbances, and restorative sleep.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety, Stress, and Mindset related to Sleep	Measured via self-report using the 7-item survey.	4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.
Dysfunctional Beliefs and Attitudes about Sleep 16-item	Sleep-related mindset, measured via self-report using the 16-item Dysfunctional Beliefs and Attitudes about Sleep, involves calculating the average of the scores from all 16 items. Higher average scores indicate a stronger endorsement of sleep-disruptive beliefs, which are considered maladaptive.	4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.
Modified Insomnia Severity Index	Severity of Sleep Problems, measured via self-report using the 5-item Insomnia Severity Index, modified to replace Insomnia with Sleep.	Week 2 and Week 4: measured twice.
Satisfaction with sleep	Measured via self-report using a single item, with scores ranging from 1 to 5, where 1 indicates very satisfied and 5 indicates very dissatisfied.	Week 2 and Week 4: measured twice.
Sleep Problems Interference with Daily Functioning	Measured via self-report using a single item, with scores ranging from 1 to 5, where 1 indicates not at all interfering and 5 indicates very much interfering.	Week 2 and Week 4: measured twice.
Pre-Sleep Arousal Scale	Pre-sleep arousal, measured via self-report using the 16-item Pre-Sleep Arousal Scale, with items rated on a 5-point Likert scale from 1 (not at all) to 5 (extremely). The sum of scores from the first 8 items reflects somatic pre-sleep arousal, and the sum of scores from the last 8 items reflects cognitive pre-sleep arousal. Clinically relevant cut-off scores will be used: ≥14 for somatic pre-sleep arousal and ≥20 for cognitive pre-sleep arousal.	4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Virtual Research Participation	Measured via self-report using the 10-item questionnaire.	Once at the end of the study, through study completion, which averages approximately 1 year.

Collaborators and Investigators

• Sponsor: NextSense, Inc.
• Investigators: Principal Investigator: Kyung Mi Kim, PhD, MandK Consulting Partners; Principal Investigator: Michele D Nelson, PhD, MandK Consulting Partners

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Actual): February 5, 2025
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): April 18, 2025
• Last Update Submitted That Met QC Criteria: April 15, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: sleep; mindset about sleep; brain-sensing buds
• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleepiness; Disorders of Excessive Somnolence
• Other Study ID Numbers: Sterling IRB #12205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No