Smart Pillows for Enhancing Sleep Quality

August 22, 2025 updated by: Chang Dae Lee, Indiana University

Smart Pillows for Enhancing Sleep Quality_Pilot Study

The purpose of this study is to examine the impact of smart pillows on the sleep quality of individuals who experience a snoring issue and/or obstructive sleep apnea (OSA), as well as their sleep partners. Furthermore, this study will explore whether enhancements in sleep quality positively influence depressive symptoms, physical activity, heart rate, blood oxygen levels, and cognitive functions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study's timeline consists of 3 phases:

  • a pre-evaluation, or baseline, phase during the 7 days prior to study pillow use,
  • an intervention phase, occurring for 14 days during study pillow use,
  • a post-evaluation phase, during the final 7 days of study pillow use.

During the Pre-Evaluation phase, participants and their sleep partners will complete questionnaires related to sleep quality and depression. Participants and sleep partners will each be asked to wear an actigraphy watch continuously for the 7 days immediately prior to the intervention phase (Study Day -7 through Study Day -1). The actigraphy watch will collect data on various objective sleep quality measures and on other health measures. Additionally, participants and sleep partners will also complete a daily sleep log and a daily sleep questionnaire during this pre-evaluation phase. The participant (individual with snoring or OSA) will also set up the pillow's control box next to the bed to collect baseline data on snoring patterns.

During the Intervention phase, participants with snoring issues or OSA will be asked to use the study pillow for 14 days (Study Day 1 through Study Day 14). The pillow features a center that detects the head position and six airbags that can add and remove air individually. If the pillow detects snoring, it will adjust the position of the participant's head by adjusting the amount of air in each airbag. This repositioning is gentle, produces minimal noise, and will not disrupt the participant's sleep or wake them. Participants will be provided with instructions on how to use the pillow. Participants may continue current snoring or OSA treatments during this time. During the intervention phase, sleep partners will be asked to continue to share a sleeping space with the participant, as they are used to doing.

The post-evaluation phase begins half-way through the intervention phase and continues through discontinuation of the study pillow (Study Day 8 through Study Day 14). During the post-evaluation phase, participants and sleep partners will repeat the assessments from the Pre-Evaluation phase, including the daily wear of the actigraphy watch and the daily sleep log and questionnaires.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chang Dae Lee, PhD
  • Phone Number: 317-274-5365
  • Email: cl150@iu.edu

Study Locations

  • United States
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Contact:
          • Chang Dae Lee, PhD
          • Phone Number: 317-274-5365
          • Email: cl150@iu.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Inclusion criteria for individuals with snoring issues or OSA

    • Individuals 50 years of age or older.
    • Individuals who experience snoring issues and/or OSA that may impact their perceived sleep quality or that of their sleep partner.
    • Individuals who currently use and do not use snoring and/or OSA treatment (participants will not be asked or required to discontinue any current snoring and/or OSA treatments that they are prescribed or using.)
    • Individuals who have a smartphone or a smart mobile device (Apple iOS 15 and higher or Android 10 or higher).
    • Individuals with and without a sleep partner.
    • Individuals who do not have a pacemaker.
    • Individuals who do not have intracranial electrodes.
    • Individuals who do not have neck pain related to the cervical spine problems, including disc, muscle, and neurological issues.

Inclusion criteria for sleep partners

  • Individuals aged 18 years and older.
  • Individuals who share the same sleeping space with their sleep partner (who has snoring issues and/or OSA) more than four times a week.
  • Individuals whose sleep partner (who has snoring issues and/or OSA) agrees to participate in this study.

Exclusion Criteria:

  • Any participant who is not able to consent or complete study interventions independently, as determined by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smart pillow group
There is one group that will receive an intervention: the utilization of a smart pillow to mitigate snoring issues and OSA symptoms.
Device: Smart pillow
Utilize a smart pillow that is designed to reduce snoring issues and OSA symptoms during sleep
Other Names:
  • Nitetronic Z6 smart pillow

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Participant Subjective Sleep Quality (PSQI)
Time Frame: Baseline and Day 14
Subjective sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI score ranges from 0-21. A higher score indicates worse sleep quality. The PSQI will be administered prior to use of the study pillow and again after discontinuing use of the study pillow.
Baseline and Day 14
Change in Participant Subjective Sleep Quality (novel sleep quality questionnaire)
Time Frame: Day -7 through Day -1 and Day 8 through Day 14
Subjective sleep quality will also be measured by a novel questionnaire created for this project. Questionnaire score ranges from 3-15. A higher score indicates better sleep quality. Participants will be asked to complete this questionnaire 14 times during their participation: once daily for the 7 days prior to initiating use of the study pillow (Day -7 through Day -1) and once daily for the last 7 days of study pillow use (Day 8 - Day 14).
Day -7 through Day -1 and Day 8 through Day 14
Change in Participant Snoring time
Time Frame: Days 1 - 14 (during use of the study pillow)
The study pillow (Nitetronic Z6 smart pillow) will collect data on total time spent snoring and the intensity of the snoring. Participants will be asked to use the study pillow for 14 consecutive nights during their participation (Day 1 through Day 14).
Days 1 - 14 (during use of the study pillow)
Change in Participant blood oxygen level
Time Frame: Day -7 through Day -1 and Day 8 through Day 14
Blood oxygen level will be measured using the Fitbit Inspire 3 (an actigraphy watch). Participants will be asked to wear the actigraphy watch continuously for the 7 days before initiating use of the study pillow (Day -7 through Day -1) and continuously for the last 7 days of study pillow use (Day 8 through Day 14).
Day -7 through Day -1 and Day 8 through Day 14
Change in Participant physical activity level
Time Frame: Day -7 through Day -1 and Day 8 through Day 14
Physical activity level will be measured using the Fitbit Inspire 3 (an actigraphy watch). Participants will be asked to wear the actigraphy watch continuously for the 7 days before initiating use of the study pillow (Day -7 through Day -1) and continuously for the last 7 days of study pillow use (Day 8 through Day 14).
Day -7 through Day -1 and Day 8 through Day 14
Change in Participant total sleep time
Time Frame: Day -7 through Day -1 and Day 8 through Day 14
As part of measuring objective sleep quality, total sleep time will be measured using the Fitbit Inspire 3 (an actigraphy watch). Participants will be asked to wear the actigraphy watch continuously for the 7 days before initiating use of the study pillow (Day -7 through Day -1) and continuously for the last 7 days of study pillow use (Day 8 through Day 14).
Day -7 through Day -1 and Day 8 through Day 14
Change in Participant sleep periods
Time Frame: Day -7 through Day -1 and Day 8 through Day 14
As part of measuring objective sleep quality, sleep periods (light and deep sleep) will be measured using the Fitbit Inspire 3 (an actigraphy watch). Participants will be asked to wear the actigraphy watch continuously for the 7 days before initiating use of the study pillow (Day -7 through Day -1) and continuously for the last 7 days of study pillow use (Day 8 through Day 14).
Day -7 through Day -1 and Day 8 through Day 14
Change in Participant REM sleep time
Time Frame: Day -7 through Day -1 and Day 8 through Day 14
As part of measuring objective sleep quality, REM and non-REM sleep time will be measured using the Fitbit Inspire 3 (an actigraphy watch). Participants will be asked to wear the actigraphy watch continuously for the 7 days before initiating use of the study pillow (Day -7 through Day -1) and continuously for the last 7 days of study pillow use (Day 8 through Day 14).
Day -7 through Day -1 and Day 8 through Day 14
Change in Participant Depressive symptoms
Time Frame: Baseline and Day 14
Depressive symptoms will be measured using the Center for Epidemiologic Studies Depression Scale, 8-item (CES-D-8). The CES-D-8 score ranges from 0 to 8. A higher score indicates more severe depressive symptoms.. The CES-D-8 will be administered prior to use of the study pillow and again after discontinuing use of the study pillow.
Baseline and Day 14
Change in Participant's subjective cognitive function
Time Frame: Baseline and Day 14
Subjective cognitive function will be measured by a two-question questionnaire: 1) 'How would you rate your memory at the present time? Would you say it is excellent, very good, good, fair, or poor?' and 2) 'Compared to the previous month, would you say your memory is better now, about the same, or worse than it was then?' The two-question questionnaire will be administered prior to the use of the study pillow and again after discontinuing the use of the study pillow.
Baseline and Day 14
Change in Participant's objective cognitive function
Time Frame: Baseline and Day 14
Objective cognitive function will measured by the Montreal Cognitive Assessment (MoCA). The MoCA score ranges from 0-30. A higher score indicates better cognitive function. The MoCA will be administered prior to the use of the study pillow and again after discontinuing the use of the study pillow.
Baseline and Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Partner Depressive symptoms
Time Frame: Baseline and Day 14
Depressive symptoms will be measured using the Center for Epidemiologic Studies Depression Scale, 8-item (CES-D-8). The CES-D-8 score ranges from 0 to 8. A higher score indicates more severe depressive symptoms. The CES-D-8 will be administered prior to use of the study pillow and again after discontinuing use of the study pillow.
Baseline and Day 14
Change in Partner's Subjective Sleep Quality (PSQI)
Time Frame: Baseline and Day 14
Subjective sleep quality will be measured by the Pittsburgh Sleep Quality Index (PSQI). The PSQI score ranges from 0-21. A higher score indicates worse sleep quality. The PSQI will be administered to sleep partners of study participants prior to the participant's use of the study pillow and again after the participant discontinues use of the study pillow.
Baseline and Day 14
Change in Partner's Subjective Sleep Quality (novel sleep quality questionnaire)
Time Frame: Days -7 through -1 and Days 8-14
Subjective sleep quality will also be measured by a novel questionnaire created for this project. Questionnaire score ranges from 3-15. A higher score indicates better sleep quality. Sleep Partners will be asked to complete this questionnaire 14 times during their participation: once daily for the 7 days prior to the participant initiating use of the study pillow (Day -7 through Day -1) and once daily during the participant's last 7 days of study pillow use (Day 8 through Day 14).
Days -7 through -1 and Days 8-14
Change in Partner's total sleep time
Time Frame: Day -7 through Day -1 and Day 8 through Day 14
As part of measuring objective sleep quality, total sleep time will be measured using the Fitbit Inspire 3 (an actigraphy watch). Sleep Partners of study participants will be asked to wear the actigraphy watch continuously for 7 days before the participant initiates use of the pillow (Day -7 through Day -1) and continuously for the last 7 days of the participant's pillow use (Day 8 through Day 14).
Day -7 through Day -1 and Day 8 through Day 14
Change in Partner's sleep periods
Time Frame: Day -7 through Day -1 and Day 8 through Day 14
As part of measuring objective sleep quality, sleep periods (light and deep sleep) will be measured using the Fitbit Inspire 3 (an actigraphy watch). Sleep Partners of study participants will be asked to wear the actigraphy watch continuously for the 7 days before the participant initiates use of the pillow (Day -7 through Day -1) and continuously for the last 7 days of the participant's pillow use (Day 8 through Day 14).
Day -7 through Day -1 and Day 8 through Day 14
Change in Partner's REM sleep time
Time Frame: Day -7 through Day -1 and Day 8 through Day 14
As part of measuring objective sleep quality, REM and non-REM sleep time will be measured using the Fitbit Inspire 3 (an actigraphy watch). Sleep Partners of study participants will be asked to wear the actigraphy watch continuously for the 7 days before the participant initiates use of the pillow (Day -7 through Day -1) and continuously for the last 7 days of the participant's pillow use (Day 8 through Day 14).
Day -7 through Day -1 and Day 8 through Day 14
Change in Partner's blood oxygen level
Time Frame: Day -7 through Day -1 and Day 8 through Day 14
Blood oxygen level will be measured using the Fitbit Inspire 3 (an actigraphy watch). Sleep Partners of study participants will be asked to wear the actigraphy watch continuously for the 7 days before the participant initiates use of the pillow (Day -7 through Day -1) and continuously for the last 7 days of the participant's pillow use (Day 8 through Day 14).
Day -7 through Day -1 and Day 8 through Day 14
Change in Partner's physical activity level
Time Frame: Day -7 through Day -1 and Day 8 through Day 14
Physical activity level will be measured using the Fitbit Inspire 3 (an actigraphy watch). Sleep Partners of study participants will be asked to wear the actigraphy watch continuously for the 7 days before the participant initiates use of the pillow (Day -7 through Day -1) and continuously for the last 7 days of the participant's pillow use (Day 8 through Day 14).
Day -7 through Day -1 and Day 8 through Day 14
Change in Partner's subjective cognitive function
Time Frame: Baseline and Day 14
Subjective cognitive function will be measured by a two-question questionnaire: 1) 'How would you rate your memory at the present time? Would you say it is excellent, very good, good, fair, or poor?' and 2) 'Compared to the previous month, would you say your memory is better now, about the same, or worse than it was then?' The two-question questionnaire will be administered prior to the use of the study pillow and again after discontinuing the use of the study pillow.
Baseline and Day 14
Change in Partner's objective cognitive function
Time Frame: Baseline and Day 14
Objective cognitive function will measured by the Montreal Cognitive Assessment (MoCA). The MoCA score ranges from 0-30. A higher score indicates better cognitive function. The MoCA will be administered prior to the use of the study pillow and again after discontinuing the use of the study pillow.
Baseline and Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indiana University

Investigators

  • Principal Investigator: Chang Dae Lee, PhD, Indiana University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 18, 2024

Primary Completion (Estimated)

July 11, 2026

Study Completion (Estimated)

July 11, 2026

Study Registration Dates

First Submitted

September 3, 2024

First Submitted That Met QC Criteria

September 10, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 22, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22402 (Other Identifier: City of Hope Medical Center)

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

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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