NCT06525337

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2024

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 29, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

August 30, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2025

Completed
Last Updated

December 9, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

July 9, 2024

Last Update Submit

December 4, 2024

Conditions

Obstructive Sleep Apnea

Keywords

OSAtelehealthAHIOxygen SaturationODI

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

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.

Behavioral: STANDARDCARE (STAND) group

CONTROL (CON) group

EXPERIMENTAL

Participants in this group will receive no device and no health coaching.

Other: CONTROL (CON) group

Interventions

STANDARDCARE (STAND) groupBEHAVIORAL

Will receive a device and health coaching

STANDARDCARE (STAND) group
CONTROL (CON) groupOTHER

Will not use any devices or receive health coaching

CONTROL (CON) group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Williams Brice Building

Conway, South Carolina, 29526, United States

Location

Neurology Clinic, P.C.

Cordova, Tennessee, 38018, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Population Groups

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

DemographyPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Individuals will be randomized to the intervention or control at the baseline. SAS version 9.4 will be used to create the randomization list.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2024

First Posted

July 29, 2024

Study Start

August 30, 2024

Primary Completion

December 29, 2024

Study Completion

March 30, 2025

Last Updated

December 9, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(2)