Smart Pillows for Enhancing Sleep Quality

Indiana University

Status

Enrolling

Conditions

Snoring

Obstructive Sleep Apnea

Treatments

Device: Smart pillow

Study type

Interventional

Funder types

Other

Identifiers

NCT06594627

22402 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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