Smart Pillows for Enhancing Sleep Quality

Официальное название

Smart Pillows for Enhancing Sleep Quality_Pilot Study

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (10)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 1 центр

• Indiana University — Indianapolis

Публикации

• 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. PMID 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. PMID 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. PMID 26163057

Идентификаторы

NCT: NCT06594627 · 22402

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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