Smart Pillows for Enhancing Sleep Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.)
Disqualifiers
Any participant who is not able to consent or complete study interventions independently, as determined by the investigator.
Trial design
Design model
Single group
Treatments tested in this trial
Smart pillow
DeviceUtilize a smart pillow that is designed to reduce snoring issues and OSA symptoms during sleep
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Smart pillow groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and Day 142
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).
Time frame
Day -7 through Day -1 and Day 8 through Day 143
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).
Time frame
Day -7 through Day -1 and Day 8 through Day 144
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).
Time frame
Day -7 through Day -1 and Day 8 through Day 14Secondary outcomes
1
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.
Time frame
Baseline and Day 142
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).
Time frame
Days -7 through -1 and Days 8-143
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).
Time frame
Day -7 through Day -1 and Day 8 through Day 144
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).
Time frame
Day -7 through Day -1 and Day 8 through Day 14Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov