SnoringNCT06594627

Smart Pillows for Enhancing Sleep Quality

A study testing Smart pillow in people with Snoring and Obstructive Sleep Apnea, run by Indiana University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Snoring, Obstructive Sleep Apnea
What is being tested?: Smart pillow
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: 18 Nov 2024to 11 Jul 2027
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Show all 12Show fewer

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.
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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Chang Dae Lee, PhD contact

317-274-5365

cl150@iu.edu

United States1 site, 1 recruiting

Indiana University
Indianapolis, Indiana, 46202
Chang Dae Lee, PhD, 317-274-5365, cl150@iu.edu
Recruiting

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Snoring, Obstructive Sleep Apnea
Being tested: Smart pillow
Keywords: assistive device, sleep quality, snoring, obstructive sleep apnea
Medical subject headings: Snoring, Sleep Apnea, Obstructive, Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Smart pillowDevice
Also called Nitetronic Z6 smart pillow
Utilize a smart pillow that is designed to reduce snoring issues and OSA symptoms during sleep

Study groups in NCT06594627
Study group	Role	What they receive
Smart pillow group	Experimental	There is one group that will receive an intervention: the utilization of a smart pillow to mitigate snoring issues and OSA symptoms. Receives: Device: Smart pillow

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Participant Subjective Sleep Quality (PSQI)
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.
Measured: Baseline and Day 14
Change in Participant Subjective Sleep Quality (novel sleep quality questionnaire)
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).
Measured: Day -7 through Day -1 and Day 8 through Day 14
Change in Participant total sleep time
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).
Measured: Day -7 through Day -1 and Day 8 through Day 14
Change in Participant sleep periods
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).
Measured: Day -7 through Day -1 and Day 8 through Day 14
Change in Participant REM sleep time
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).
Measured: Day -7 through Day -1 and Day 8 through Day 14
Change in Participant Snoring time
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).
Measured: Days 1 - 14 (during use of the study pillow)
Change in Participant Depressive symptoms
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.
Measured: Baseline and Day 14
Change in Participant blood oxygen level
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).
Measured: Day -7 through Day -1 and Day 8 through Day 14
Change in Participant physical activity level
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).
Measured: Day -7 through Day -1 and Day 8 through Day 14
Change in Participant's subjective cognitive function
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.
Measured: Baseline and Day 14
Change in Participant's objective cognitive function
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.
Measured: Baseline and Day 14

Secondary outcomes (10)

Change in Partner's Subjective Sleep Quality (PSQI)
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.
Measured: Baseline and Day 14
Change in Partner's Subjective Sleep Quality (novel sleep quality questionnaire)
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).
Measured: Days -7 through -1 and Days 8-14
Change in Partner's total sleep time
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).
Measured: Day -7 through Day -1 and Day 8 through Day 14
Change in Partner's sleep periods
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).
Measured: Day -7 through Day -1 and Day 8 through Day 14
Change in Partner's REM sleep time
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).
Measured: Day -7 through Day -1 and Day 8 through Day 14
Change in Partner Depressive symptoms
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.
Measured: Baseline and Day 14
Change in Partner's blood oxygen level
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).
Measured: Day -7 through Day -1 and Day 8 through Day 14
Change in Partner's physical activity level
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).
Measured: Day -7 through Day -1 and Day 8 through Day 14
Change in Partner's subjective cognitive function
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.
Measured: Baseline and Day 14
Change in Partner's objective cognitive function
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.
Measured: Baseline and Day 14

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Nov 202411 Jul 2027

First posted19 Sep 2024
Study start18 Nov 2024
Primary completion11 Jul 2027 (estimated)
Study completion11 Jul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for SnoringStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Model description: It is a single group, pre- and post- test/eval design.
Masking: None (open label)
Enrolment: 24 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06594627
Sponsor's protocol ID: 22402
Status last verified: Aug 2026
First submitted: 3 Sep 2024
Last updated: 21 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Rădulescu PV. The Elderly Technically Sleep A Study into the Use of a Smart Breathing Pillow to Improve Sleep in the Elderly Population. 2024;
Radwan A, Fess P, James D, Murphy J, Myers J, Rooney M, Taylor J, Torii A. Effect of different mattress designs on promoting sleep quality, pain reduction, and spinal alignment in adults with or without back pain; systematic review of controlled trials. Sleep Health. 2015 Dec;1(4):257-267. doi: 10.1016/j.sleh.2015.08.001. Epub 2015 Oct 19.
PubMed 29073401
Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019
Ofstedal MB, Fisher GG, Herzog AR. Documentation of Cognitive Functioning Measures in the Health and Retirement Study. 2005. http://hrsonline.isr.umich.edu/sitedocs/userg/dr-006.pdf
Chau B. Fitabase makes activity data from Fitbit devices easily accessible for research. iMedicalApps Accessed April 18, 2024. https://www.imedicalapps.com/2016/11/fitbase-fitbit-activity-research/
Steffick DE. Documentation of Affective Functioning Measures in the Health and Retirement Study. 2000. http://hrsonline.isr.umich.edu/sitedocs/userg/dr-005.pdf
McGuire J. Fitbit Inspire 3 review: the top affordable fitness tracker just got better. Tom's Guide. Accessed April 18, 2024. https://www.tomsguide.com/reviews/fitbit-inspire-3
Mollayeva T, Thurairajah P, Burton K, Mollayeva S, Shapiro CM, Colantonio A. The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: A systematic review and meta-analysis. Sleep Med Rev. 2016 Feb;25:52-73. doi: 10.1016/j.smrv.2015.01.009. Epub 2015 Feb 17.
PubMed 26163057
Chung TT, Lee MT, Ku MC, Yang KC, Wei CY. Efficacy of a Smart Antisnore Pillow in Patients with Obstructive Sleep Apnea Syndrome. Behav Neurol. 2021 Jan 14;2021:8824011. doi: 10.1155/2021/8824011. eCollection 2021.
PubMed 33510821
Virk JS, Kotecha B. When continuous positive airway pressure (CPAP) fails. J Thorac Dis. 2016 Oct;8(10):E1112-E1121. doi: 10.21037/jtd.2016.09.67.
PubMed 27867577
Ghadiri M, Grunstein RR. Clinical side effects of continuous positive airway pressure in patients with obstructive sleep apnoea. Respirology. 2020 Jun;25(6):593-602. doi: 10.1111/resp.13808. Epub 2020 Mar 24.
PubMed 32212210
Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015. J Clin Sleep Med. 2015 Jul 15;11(7):773-827. doi: 10.5664/jcsm.4858.
PubMed 26094920
Albakri U, Drotos E, Meertens R. Sleep Health Promotion Interventions and Their Effectiveness: An Umbrella Review. Int J Environ Res Public Health. 2021 May 21;18(11):5533. doi: 10.3390/ijerph18115533.
PubMed 34064108
Maness DL, Khan M. Nonpharmacologic Management of Chronic Insomnia. Am Fam Physician. 2015 Dec 15;92(12):1058-64.
PubMed 26760592
Alshaer H, Hummel R, Mendelson M, Marshal T, Bradley TD. Objective Relationship Between Sleep Apnea and Frequency of Snoring Assessed by Machine Learning. J Clin Sleep Med. 2019 Mar 15;15(3):463-470. doi: 10.5664/jcsm.7676.
PubMed 30853041

Interested in taking part?

Chang Dae Lee, PhD

317-274-5365

cl150@iu.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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RecruitingObservational study
OSAHS Screening in Diverse Populations
Obstructive Sleep Apnea (OSA), Snoring

All Snoring trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Smart Pillows for Enhancing Sleep Quality_Pilot Study
ClinicalTrials.gov ID: NCT06594627
Acronym / sponsor ID: 22402
Conditions: Snoring, Obstructive Sleep Apnea
Keywords: assistive device, sleep quality, snoring, obstructive sleep apnea
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 24 participants (estimated)
Lead sponsor: Indiana UniversityUniversity, hospital or other
Study start: 18 Nov 2024 (actual)
Primary completion: 11 Jul 2027 (estimated)
Study completion: 11 Jul 2027 (estimated)
First posted: 19 Sep 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: It is a single group, pre- and post- test/eval design.

Arm	Type	Receives
Smart pillow group	Experimental	Device: Smart pillowThere is one group that will receive an intervention: the utilization of a smart pillow to mitigate snoring issues and OSA symptoms.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Inclusion criteria for individuals with snoring issues or OSA
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.

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Smart pillowAlso: Nitetronic Z6 smart pillowUtilize a smart pillow that is designed to reduce snoring issues and OSA symptoms during sleep	Device	Smart pillow group

Primary outcome

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.
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).
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).
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).
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).
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).
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.
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).
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).
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.
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.

10 secondary outcomes

Change in Partner's Subjective Sleep Quality (PSQI)
Time frame: 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
Change in Partner's total sleep time
Time frame: 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
Change in Partner's REM sleep time
Time frame: Day -7 through Day -1 and Day 8 through Day 14
Change in Partner Depressive symptoms
Time frame: Baseline and Day 14
Change in Partner's blood oxygen level
Time frame: 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
Change in Partner's subjective cognitive function
Time frame: Baseline and Day 14
Change in Partner's objective cognitive function
Time frame: Baseline and Day 14

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
BackgroundRădulescu PV. The Elderly Technically Sleep A Study into the Use of a Smart Breathing Pillow to Improve Sleep in the Elderly Population. 2024;
Background: PubMed 29073401Radwan A, Fess P, James D, Murphy J, Myers J, Rooney M, Taylor J, Torii A. Effect of different mattress designs on promoting sleep quality, pain reduction, and spinal alignment in adults with or without back pain; systematic review of controlled trials. Sleep Health. 2015 Dec;1(4):257-267. doi: 10.1016/j.sleh.2015.08.001. Epub 2015 Oct 19.
Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
BackgroundOfstedal MB, Fisher GG, Herzog AR. Documentation of Cognitive Functioning Measures in the Health and Retirement Study. 2005. http://hrsonline.isr.umich.edu/sitedocs/userg/dr-006.pdf
BackgroundChau B. Fitabase makes activity data from Fitbit devices easily accessible for research. iMedicalApps Accessed April 18, 2024. https://www.imedicalapps.com/2016/11/fitbase-fitbit-activity-research/
BackgroundSteffick DE. Documentation of Affective Functioning Measures in the Health and Retirement Study. 2000. http://hrsonline.isr.umich.edu/sitedocs/userg/dr-005.pdf
BackgroundMcGuire J. Fitbit Inspire 3 review: the top affordable fitness tracker just got better. Tom's Guide. Accessed April 18, 2024. https://www.tomsguide.com/reviews/fitbit-inspire-3
Background: PubMed 26163057Mollayeva T, Thurairajah P, Burton K, Mollayeva S, Shapiro CM, Colantonio A. The Pittsburgh sleep quality index as a screening tool for sleep dysfunction in clinical and non-clinical samples: A systematic review and meta-analysis. Sleep Med Rev. 2016 Feb;25:52-73. doi: 10.1016/j.smrv.2015.01.009. Epub 2015 Feb 17.
Background: PubMed 33510821Chung TT, Lee MT, Ku MC, Yang KC, Wei CY. Efficacy of a Smart Antisnore Pillow in Patients with Obstructive Sleep Apnea Syndrome. Behav Neurol. 2021 Jan 14;2021:8824011. doi: 10.1155/2021/8824011. eCollection 2021.
Background: PubMed 27867577Virk JS, Kotecha B. When continuous positive airway pressure (CPAP) fails. J Thorac Dis. 2016 Oct;8(10):E1112-E1121. doi: 10.21037/jtd.2016.09.67.
Background: PubMed 32212210Ghadiri M, Grunstein RR. Clinical side effects of continuous positive airway pressure in patients with obstructive sleep apnoea. Respirology. 2020 Jun;25(6):593-602. doi: 10.1111/resp.13808. Epub 2020 Mar 24.
Background: PubMed 26094920Ramar K, Dort LC, Katz SG, Lettieri CJ, Harrod CG, Thomas SM, Chervin RD. Clinical Practice Guideline for the Treatment of Obstructive Sleep Apnea and Snoring with Oral Appliance Therapy: An Update for 2015. J Clin Sleep Med. 2015 Jul 15;11(7):773-827. doi: 10.5664/jcsm.4858.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Chang Dae Lee, PhD contact

317-274-5365

cl150@iu.edu

Chang Dae Lee, PhD principal investigator

Indiana University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Smart pillow in people with Snoring and Obstructive Sleep Apnea, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Chang Dae Lee, PhD (317-274-5365, cl150@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Participant Subjective Sleep Quality (PSQI) (time frame: Baseline and Day 14). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06594627, which also lists 19 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.