Smart Pillows for Improved Sleep in Snoring and OSA Patients
Smart pillow
Apnea+13
+ Mental Disorders
+ Nervous System Diseases
Supportive Care Study
Summary
Study start date: November 18, 2024
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 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. Exclusion Criteria: Any participant who is not able to consent or complete study interventions independently, as determined by the investigator.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location