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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.
The study's timeline consists of 3 phases:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smart pillow | Device | Utilize a smart pillow that is designed to reduce snoring issues and OSA symptoms during sleep |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Inclusion criteria for individuals with snoring issues or OSA
Inclusion criteria for sleep partners
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Dae Lee, PhD | Contact | 317-274-5365 | cl150@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Chang Dae Lee, PhD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Rădulescu PV. The Elderly Technically Sleep A Study into the Use of a Smart Breathing Pillow to Improve Sleep in the Elderly Population. 2024; | ||
| 29073401 | 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. | |
| 15817019 |
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| ID | Term |
|---|---|
| D012913 | Snoring |
| D020181 | Sleep Apnea, Obstructive |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D012135 | Respiratory Sounds |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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It is a single group, pre- and post- test/eval design.
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| 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 |
| 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). | 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). | 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). | 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). | 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. | 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). | 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). | 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. | 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. | Baseline and Day 14 |
| 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. |
| 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 |
| 26163057 | 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. |
| 33510821 | 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. |
| 27867577 | 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. |
| 32212210 | 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. |
| 26094920 | 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. |
| 34064108 | 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. |
| 26760592 | Background | Maness DL, Khan M. Nonpharmacologic Management of Chronic Insomnia. Am Fam Physician. 2015 Dec 15;92(12):1058-64. |
| 30853041 | 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. |
| 27568340 | 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. |
| Background | Elflein J. Share of U.S. adults who snored as of 2022, by age group. Statista. Accessed April 17, 2024. |
| 16227718 | 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. |
| 26101650 | 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. |
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |