Obstructive Sleep ApneaNCT06525337
Adherence to Health Coaching with Wearable Devices: Enhancing Patient Engagement and Outcomes
A study testing STANDARDCARE (STAND) group in people with Obstructive Sleep Apnea, run by Coastal Carolina University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- STANDARDCARE (STAND) group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Aug 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older
- Both genders
- All ethnicities
- Must reside in the state of TN
- Newly diagnosed with obstructive sleep apnea (OSA)
- Prescribed with moderate to severe OSA.7). AHI of > 15
Who cannot join
- Unable or unwilling to use wearable device,
- end stage renal failure
- heart failure or stroke
- Although not anticipated for this study population, women cannot be or suspect they may be pregnant.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Williams Brice Building
Conway, South Carolina, 29526
Neurology Clinic, P.C.
Cordova, Tennessee, 38018
About this study
Official title: Adherence of Health Coaching with Wearable Device
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?
Read more
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- STANDARDCARE (STAND) group, CONTROL (CON) group
- Keywords
- OSA, telehealth, AHI, Oxygen Saturation, ODI
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STANDARDCARE (STAND) groupBehavioural
Will receive a device and health coaching
CONTROL (CON) groupOther
Will not use any devices or receive health coaching
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: STANDARDCARE (STAND) group |
| CONTROL (CON) group | Experimental | Participants in this group will receive no device and no health coaching. Receives: Other: CONTROL (CON) group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Through Study Completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start30 Aug 2024
- Primary completion29 Dec 2024 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coastal Carolina University
- Sponsor type
- University, hospital or other
- Collaborators
- Apnimed, inHealth Medical Services, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06525337
- Sponsor's protocol ID
- 2024.182
- Status last verified
- Jul 2024
- First submitted
- 9 Jul 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adherence of Health Coaching with Wearable Device
- ClinicalTrials.gov ID
- NCT06525337
- Acronym / sponsor ID
- 2024.182
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, telehealth, AHI, Oxygen Saturation, ODI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Coastal Carolina UniversityUniversity, hospital or other
- Collaborators
- Apnimed, inHealth Medical Services, Inc.
- Study start
- 30 Aug 2024 (actual)
- Primary completion
- 29 Dec 2024 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| STANDARDCARE (STAND) group | Experimental | Behavioral: STANDARDCARE (STAND) groupParticipants 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 | Other: CONTROL (CON) groupParticipants in this group will receive no device and no health coaching. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 18 years or older
- Both genders
- All ethnicities
- Must reside in the state of TN
- Newly diagnosed with obstructive sleep apnea (OSA)
Key exclusion criteria (4 listed)
- Unable or unwilling to use wearable device,
- end stage renal failure
- heart failure or stroke
- Although not anticipated for this study population, women cannot be or suspect they may be pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STANDARDCARE (STAND) groupWill receive a device and health coaching | Behavioural | STANDARDCARE (STAND) group |
| CONTROL (CON) groupWill not use any devices or receive health coaching | Other | CONTROL (CON) group |
Primary outcome
Oxygen Desaturation Index (ODI)
Time frame: Daily for 90 days
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.
Quality-of-life survey responses
Time frame: Through Study Completion, an average of 3 months
Quality-of-life survey responses assess an individual's overall well-being, encompassing physical, mental, and social health.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STANDARDCARE (STAND) group in people with Obstructive Sleep Apnea, run by Coastal Carolina University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen Desaturation Index (ODI) (time frame: Daily for 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2024.