Smart Pillows for Enhancing Sleep Quality

Not Applicable

Recruiting

• Conditions: Snoring; Obstructive Sleep Apnea

• Registration Number: NCT06594627
• Lead Sponsor: Indiana University

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.

Study Timeline

• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-10
• Study First Posted: 2024-09-19
• Study Start: 2024-11-18
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-07-11
• Study Completion: 2025-07-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 24

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Participant Subjective Sleep Quality (PSQI)	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)	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	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	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	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	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	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	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	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	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	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States