Recruiting

Smart Pillows

Sponsor:

Indiana University

Code:

NCT06594627

Conditions

Snoring

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Smart pillow

Study Details

Brief summary:

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.

Conditions

Snoring

Obstructive Sleep Apnea

Study ID

NCT06594627

Start date

Nov 18, 2024

Status verified date

Aug, 2026

Completion date

Jul 11, 2027

Anticipated

Primary completion date

Jul 11, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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 Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

Interventions

Smart pillow

Utilize a smart pillow that is designed to reduce snoring issues and OSA symptoms during sleep

Primary outcome measure

  • Change in Participant Subjective Sleep Quality (PSQI) [ Time Frame: 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 ]
  • Change in Participant total sleep time [ Time Frame: 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 ]
  • Change in Participant REM sleep time [ Time Frame: 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) ]
  • Change in Participant Depressive symptoms [ Time Frame: Baseline and Day 14 ]
  • Change in Participant blood oxygen level [ Time Frame: 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 ]
  • Change in Participant's subjective cognitive function [ Time Frame: Baseline and Day 14 ]
  • Change in Participant's objective cognitive function [ Time Frame: Baseline and Day 14 ]

Central Contacts and Locations

Central contacts

Chang Dae Lee, PhD

317-274-5365cl150@iu.edu

Locations

Indiana University

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Chang Dae Lee, PhD

317-274-5365cl150@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Keywords

  • assistive device
  • sleep quality
  • snoring
  • obstructive sleep apnea

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Indiana University on 2026-08-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.