Smart Pillows for Enhancing Sleep Quality

NCT06594627 | Recruiting FDA Device

• 1 other identifier: 22402
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

assistive device; sleep quality; snoring; obstructive sleep apnea

Outcome Measures

Primary Outcomes (11)

• 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.

  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).

  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).

  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).

  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).

  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).

  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.

  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).

  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).

  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.

  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.

  Baseline and Day 14

Secondary Outcomes (10)

• Change in Partner's Subjective Sleep Quality (PSQI)

  Baseline and Day 14

• Change in Partner's Subjective Sleep Quality (novel sleep quality questionnaire)

  Days -7 through -1 and Days 8-14

• Change in Partner's total sleep time

  Day -7 through Day -1 and Day 8 through Day 14

• Change in Partner's sleep periods

  Day -7 through Day -1 and Day 8 through Day 14

• Change in Partner's REM sleep time

  Day -7 through Day -1 and Day 8 through Day 14

Study Arms (1)

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.

Device: Smart pillow

Interventions

Smart pillow DEVICE

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

Also known as: Nitetronic Z6 smart pillow

Smart pillow group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (19)

• Rădulescu PV. The Elderly Technically Sleep A Study into the Use of a Smart Breathing Pillow to Improve Sleep in the Elderly Population. 2024;

  BACKGROUND

• 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.

  PMID: 29073401 BACKGROUND

• 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.

  PMID: 15817019 BACKGROUND

• 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

  BACKGROUND

• 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/

  BACKGROUND

• Steffick DE. Documentation of Affective Functioning Measures in the Health and Retirement Study. 2000. http://hrsonline.isr.umich.edu/sitedocs/userg/dr-005.pdf

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 26163057 BACKGROUND

• 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.

  PMID: 33510821 BACKGROUND

• 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.

  PMID: 27867577 BACKGROUND

• 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.

  PMID: 32212210 BACKGROUND

• 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.

  PMID: 26094920 BACKGROUND

• 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.

  PMID: 34064108 BACKGROUND

• Maness DL, Khan M. Nonpharmacologic Management of Chronic Insomnia. Am Fam Physician. 2015 Dec 15;92(12):1058-64.

  PMID: 26760592 BACKGROUND

• 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.

  PMID: 30853041 BACKGROUND

• Senaratna CV, Perret JL, Lodge CJ, Lowe AJ, Campbell BE, Matheson MC, Hamilton GS, Dharmage SC. Prevalence of obstructive sleep apnea in the general population: A systematic review. Sleep Med Rev. 2017 Aug;34:70-81. doi: 10.1016/j.smrv.2016.07.002. Epub 2016 Jul 18.

  PMID: 27568340 BACKGROUND

• Elflein J. Share of U.S. adults who snored as of 2022, by age group. Statista. Accessed April 17, 2024.

  BACKGROUND

• Kara CO, Zencir M, Topuz B, Ardic N, Kocagozoglu B. [The prevalence of snoring in adult population]. Kulak Burun Bogaz Ihtis Derg. 2005;14(1-2):18-24. Turkish.

  PMID: 16227718 BACKGROUND

• Garvey JF, Pengo MF, Drakatos P, Kent BD. Epidemiological aspects of obstructive sleep apnea. J Thorac Dis. 2015 May;7(5):920-9. doi: 10.3978/j.issn.2072-1439.2015.04.52.

  PMID: 26101650 BACKGROUND

MeSH Terms

Conditions

Snoring; Sleep Apnea, Obstructive; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Respiratory Sounds; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Chang Dae Lee, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang Dae Lee, PhD

CONTACT

317-274-5365; cl150@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: It is a single group, pre- and post- test/eval design.

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): July 11, 2026
• Study Completion (Estimated): July 11, 2026
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)