Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06525337
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Adherence to Health Coaching With Wearable Devices Enhancing Patient Engagement and Outcomes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Adherence of Health Coaching With Wearable Device
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn how integrating health and wellness coaching HWC with Continuous Positive Airway Pressure CPAP therapy affects adherence to treatment and overall health outcomes in individuals with obstructive sleep apnea The main questions it aims to answer are
Does HWC improve CPAP adherence compared to standard care in terms of device usage metrics hours per night and days per month
How does combining HWC with weight management influence CPAP adherence and weight loss
What are the differences in treatment outcomes between individuals receiving standard care and those receiving HWC
Researchers will compare two groups
Standard Care Group Participants receiving standard CPAP therapy without additional health coaching
HWC Group Participants receiving CPAP therapy combined with health and wellness coaching focused on weight management and sleep hygiene
Participants will
Attend 2 in-office visits with a study physician 2 hours maximum
Have 6 virtual visits via video with a study health coach 3 hours maximum if in the HWC group This study aims to provide valuable insights into enhancing treatment outcomes for individuals with sleep apnea by integrating health coaching with CPAP therapy
Does HWC improve CPAP adherence compared to standard care in terms of device usage metrics hours per night and days per month
How does combining HWC with weight management influence CPAP adherence and weight loss
What are the differences in treatment outcomes between individuals receiving standard care and those receiving HWC
Researchers will compare two groups
Standard Care Group Participants receiving standard CPAP therapy without additional health coaching
HWC Group Participants receiving CPAP therapy combined with health and wellness coaching focused on weight management and sleep hygiene
Participants will
Attend 2 in-office visits with a study physician 2 hours maximum
Have 6 virtual visits via video with a study health coach 3 hours maximum if in the HWC group This study aims to provide valuable insights into enhancing treatment outcomes for individuals with sleep apnea by integrating health coaching with CPAP therapy
Detailed Description:
Purpose
The purpose of this research study is to compare the effects of a wearable sleep ring combined with health coaching in the STANDARDCARE STAND group to a CONTROL CON group with no sleep ring and no health coaching The investigators aim to see if this combination improves patient satisfaction and progress with using a CPAP machine
Procedures
If participants agree to participate they will be asked to do the following
Baseline Assessment
Participants will attend a baseline assessment with their doctor that includes an overview and explanation of the study They will conduct all standardized sleep tests as advised by their doctor Upon meeting inclusion criteria they will then be randomized to a STANDARDCARE STAND group or CONTROL CON group During this time body weight and height will be measured Participants will then be asked to fill out several surveys that will involve questions related to overall health quality of life sleep adherence and demographics age race
STANDARDCARE GROUP STAND
If participants are randomized to this group they will be asked to download one app They will first be asked to download the Apnimed App which will be used for collecting wearable sleep ring data daily Participants will also be given step-by-step instructions on how to use the app They will be asked to use the Apnimed sleep ring every night and sync data on the app in the morning Following the initial baseline visit participants will receive weekly individualized video health coaching sessions with a health coach through video conference using Zoom for 6 weeks During these sessions they will receive weekly educational online modules focusing on sleep nutrition and fitness centered on sleep science and adherence to the CPAP machine Participants will be able to keep using the ring as much or as little as desired after the 6-week period The research team will administer the final survey at 3 months following participants first usage of the ring Participants will fill out a survey at the beginning of the study at 6 weeks and 3 months after enrolling
CONTROL GROUP CON
If participants are randomized to this group they will not receive any wearable sleep ring or health coaching They will have two visits with the study physician at baseline and at the end of the study Participants will only be instructed to use the CPAP machine daily or undergo standard medical treatment as prescribed They will be asked to fill out the surveys again at the end of 6 weeks and 3 months
The purpose of this research study is to compare the effects of a wearable sleep ring combined with health coaching in the STANDARDCARE STAND group to a CONTROL CON group with no sleep ring and no health coaching The investigators aim to see if this combination improves patient satisfaction and progress with using a CPAP machine
Procedures
If participants agree to participate they will be asked to do the following
Baseline Assessment
Participants will attend a baseline assessment with their doctor that includes an overview and explanation of the study They will conduct all standardized sleep tests as advised by their doctor Upon meeting inclusion criteria they will then be randomized to a STANDARDCARE STAND group or CONTROL CON group During this time body weight and height will be measured Participants will then be asked to fill out several surveys that will involve questions related to overall health quality of life sleep adherence and demographics age race
STANDARDCARE GROUP STAND
If participants are randomized to this group they will be asked to download one app They will first be asked to download the Apnimed App which will be used for collecting wearable sleep ring data daily Participants will also be given step-by-step instructions on how to use the app They will be asked to use the Apnimed sleep ring every night and sync data on the app in the morning Following the initial baseline visit participants will receive weekly individualized video health coaching sessions with a health coach through video conference using Zoom for 6 weeks During these sessions they will receive weekly educational online modules focusing on sleep nutrition and fitness centered on sleep science and adherence to the CPAP machine Participants will be able to keep using the ring as much or as little as desired after the 6-week period The research team will administer the final survey at 3 months following participants first usage of the ring Participants will fill out a survey at the beginning of the study at 6 weeks and 3 months after enrolling
CONTROL GROUP CON
If participants are randomized to this group they will not receive any wearable sleep ring or health coaching They will have two visits with the study physician at baseline and at the end of the study Participants will only be instructed to use the CPAP machine daily or undergo standard medical treatment as prescribed They will be asked to fill out the surveys again at the end of 6 weeks and 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None