Nextsense Brain-sensing Buds Study

NCT06602960 | Terminated

• 1 other identifier: Sterling IRB #12205
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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. 1.Does receiving sleep-related feedback from a wearable sleep tracker affect an individual\'s mindset about sleep?
2. 2.How does the mindset about sleep influence sleep quality, sleepiness, and stress/anxiety levels related to sleep?
3. 3.Does the feedback on sleep data moderate the relationship between one\'s mindset about sleep and their sleep quality?
4. 4.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.
5. 5.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.
6. 6.For Weeks 3-4, wear a Fitbit and Brain-Sensing earbuds, receiving daily feedback on their sleep.
7. 7.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

Keywords

sleep; mindset about sleep; brain-sensing buds

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Anxiety, Stress, and Mindset related to Sleep

  4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.

• Dysfunctional Beliefs and Attitudes about Sleep 16-item

  4 weeks (Week 1 - Week 4): measured at baseline, in weekly surveys.

• Modified Insomnia Severity Index

  Week 2 and Week 4: measured twice.

• Satisfaction with sleep

  Week 2 and Week 4: measured twice.

• Sleep Problems Interference with Daily Functioning

  Week 2 and Week 4: measured twice.

Other Outcomes (1)

• Virtual Research Participation

  Once at the end of the study, through study completion, which averages approximately 1 year.

Study Arms (4)

Control Group

ACTIVE COMPARATOR

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

Intervention Group 1

EXPERIMENTAL

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

Intervention Group 2

EXPERIMENTAL

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

Intervention Group 3

EXPERIMENTAL

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

Interventions

Accurate Sleep Data Feedback BEHAVIORAL

Participants will receive accurate feedback about their sleep data.

Control Group

Inflated Sleep Data Feedback BEHAVIORAL

Participants will receive inflated feedback about their sleep data, suggesting better sleep quality than detected by Fitbit (actual sleep hours +10%).

Intervention Group 1

Deflated Sleep Data Feedback BEHAVIORAL

Participants will receive deflated feedback about their sleep data, suggesting poorer sleep quality than detected by Fitbit (actual sleep hours -10%).

Intervention Group 2

Accurate Sleep Data Feedback + Sleep-related Educational Information BEHAVIORAL

Participants will receive accurate feedback about their sleep data along with sleep-related educational information.

Intervention Group 3

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• NextSense, Inc.: lead

Study Sites (1)

Alethios (Virtual Study Platform)

San Francisco, California, 94109, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Disorders of Excessive Somnolence

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Kyung Mi Kim, PhD

  MandK Consulting Partners

  PRINCIPAL INVESTIGATOR

• Michele D Nelson, PhD

  MandK Consulting Partners

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: October 7, 2024
• Primary Completion: February 5, 2025
• Study Completion: April 15, 2025
• Last Updated: April 18, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)