Clinical trial NCT06594627: Smart Pillows for Enhancing Sleep Quality
Official title: Smart Pillows for Enhancing Sleep Quality_Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Snoring
Obstructive Sleep Apnea
Keywords: assistive device
sleep quality
snoring
obstructive sleep apnea
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: It is a single group, pre- and post- test/eval design.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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 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 investigator.

Primary outcomes:
measure: Change in Participant Subjective Sleep Quality (PSQI)
timeFrame: Baseline and Day 14
measure: Change in Participant Subjective Sleep Quality (novel sleep quality questionnaire)
timeFrame: Day -7 through Day -1 and Day 8 through Day 14
measure: Change in Participant total sleep time
timeFrame: Day -7 through Day -1 and Day 8 through Day 14
measure: Change in Participant sleep periods
timeFrame: Day -7 through Day -1 and Day 8 through Day 14
measure: Change in Participant REM sleep time
timeFrame: Day -7 through Day -1 and Day 8 through Day 14
measure: Change in Participant Snoring time
timeFrame: Days 1 - 14 (during use of the study pillow)
measure: Change in Participant Depressive symptoms
timeFrame: Baseline and Day 14
measure: Change in Participant blood oxygen level
timeFrame: Day -7 through Day -1 and Day 8 through Day 14
measure: Change in Participant physical activity level
timeFrame: Day -7 through Day -1 and Day 8 through Day 14
measure: Change in Participant's subjective cognitive function
timeFrame: Baseline and Day 14
measure: Change in Participant's objective cognitive function
timeFrame: Baseline and Day 14
Secondary outcomes:
measure: Change in Partner Subjective Sleep Quality (PSQI)
timeFrame: Baseline and Day 14
measure: Change in Partner Subjective Sleep Quality (novel sleep quality questionnaire)
timeFrame: Days -7 through -1 and Days 8-14
measure: Change in Partner total sleep time
timeFrame: Day -7 through Day -1 and Day 8 through Day 14
measure: Change in Partner sleep periods
timeFrame: Day -7 through Day -1 and Day 8 through Day 14
measure: Change in Partner REM sleep time
timeFrame: Day -7 through Day -1 and Day 8 through Day 14
measure: Change in Partner Depressive symptoms
timeFrame: Baseline and Day 14
measure: Change in Partner blood oxygen level
timeFrame: Day -7 through Day -1 and Day 8 through Day 14
measure: Change in Partner physical activity level
timeFrame: Day -7 through Day -1 and Day 8 through Day 14
measure: Change in Participant's subjective cognitive function
timeFrame: Baseline and Day 14
measure: Change in Participant's objective cognitive function
timeFrame: Baseline and Day 14
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Chang Dae Lee, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rădulescu PV. The Elderly Technically Sleep A Study into the Use of a Smart Breathing Pillow to Improve Sleep in the Elderly Population. 2024;
citation: 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.
citation: 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.
citation: 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
citation: 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/
citation: Steffick DE. Documentation of Affective Functioning Measures in the Health and Retirement Study. 2000. http://hrsonline.isr.umich.edu/sitedocs/userg/dr-005.pdf
citation: McGuire J. Fitbit Inspire 3 review: the top affordable fitness tracker just got better. Tom&#39;s Guide. Accessed April 18, 2024. https://www.tomsguide.com/reviews/fitbit-inspire-3
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Maness DL, Khan M. Nonpharmacologic Management of Chronic Insomnia. Am Fam Physician. 2015 Dec 15;92(12):1058-64.
citation: 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.
citation: 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.
citation: Elflein J. Share of U.S. adults who snored as of 2022, by age group. Statista. Accessed April 17, 2024.
citation: 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.
citation: 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.