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| Name | Class |
|---|---|
| Apnimed | INDUSTRY |
| inHealth Medical Services, Inc. | INDUSTRY |
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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:
Researchers will compare two groups:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STANDARDCARE (STAND) group | Experimental | Participants will download the Apnimed App for daily sleep ring data collection, using it nightly and syncing data each morning. They will receive weekly video health coaching sessions for 6 weeks, focusing on sleep, nutrition, and CPAP adherence. Surveys will be completed at baseline, 6 weeks, and 3 months. |
|
| CONTROL (CON) group | Experimental | Participants in this group will receive no device and no health coaching. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STANDARDCARE (STAND) group | Behavioral | Will receive a device and health coaching |
|
| Measure | Description | Time Frame |
|---|---|---|
| Oxygen Desaturation Index (ODI) | The ODI is a measurement that helps diagnose and manage obstructive sleep apnea (OSA) by quantifying how often and how much a person's blood oxygen level drops during sleep. | Daily for 90 days |
| Quality-of-life survey responses | Quality-of-life survey responses assess an individual's overall well-being, encompassing physical, mental, and social health. | Through Study Completion, an average of 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Williams Brice Building | Conway | South Carolina | 29526 | United States | ||
| Neurology Clinic, P.C. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D044382 | Population Groups |
| ID | Term |
|---|---|
| D003710 | Demography |
| D011154 | Population Characteristics |
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All participants were randomized in a balanced fashion and stratified by sex and AHI number into either one of the two intervention groups STANDARDCARE group (STAND) compared to no sleep ring and health coaching CONTROL group (CON) group
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Individuals will be randomized to the intervention or control at the baseline. SAS version 9.4 will be used to create the randomization list.
| CONTROL (CON) group | Other | Will not use any devices or receive health coaching |
|
| Cordova |
| Tennessee |
| 38018 |
| United States |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |