NCT06039865

Brief Summary

The goal of this clinical trial in adults with obstructive sleep apnea prescribed positive airway pressure therapy is to test the effects of a new patient-facing consumer wearable-based program (that involves provision of a consumer wearable that measures oxygen levels during sleep plus customized weekly reports to participants). The main question is to learn whether participants' use of positive airway pressure therapy will differ between the participants who receive the new program immediately versus delayed. Participants assigned to the delayed program will receive usual care while waiting for the program to begin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 15, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 20, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 21, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 21, 2025

Completed
Last Updated

January 27, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

September 8, 2023

Last Update Submit

January 22, 2025

Conditions

Obstructive Sleep Apnea

Keywords

WearablePulse oximetrySleep apneaTreatment adherence

Outcome Measures

Primary Outcomes (1)

  • PAP adherence (minutes)

    Change in mean minutes of PAP use per night between baseline (T1) and post-treatment (T3).

    5 weeks

Secondary Outcomes (1)

  • PAP adherence (percent of days used >= 4 hours)

    5 weeks

Study Arms (2)

Immediate Intervention

EXPERIMENTAL

Participants will be provided with a consumer wearable immediately after randomization to wear for 4 weeks.

Behavioral: Immediate Intervention

Waitlist control

OTHER

Participants will receive usual care from the sleep center for 6 weeks and then be provided with a consumer wearable to wear for 4 weeks.

Behavioral: Waitlist control

Interventions

Immediate InterventionBEHAVIORAL

Participants will receive customized weekly reports from the pulse oximetry data collected by the consumer wearable.

Immediate Intervention
Waitlist controlBEHAVIORAL

Participants only receive usual care from the sleep center.

Waitlist control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Prescribed PAP therapy from the sleep center for \> 1 week
  • Have an active profile in our Center's ResMed AirView or Respironics Care Orchestrator accounts for \> 1 week
  • Non-adherent with PAP therapy
  • Willing to continue using current PAP device for 28 days continuously
  • Have an electronic device compatible with the wearable app

You may not qualify if:

  • Diagnosis of heart failure, chronic lung disease, dementia, active substance use disorder
  • Use home oxygen
  • Unstable medical or psychiatric illness
  • Planned non-use of PAP therapy (e.g., waiting for replacement of recalled PAP device)
  • Planned surgery or hospitalization during study period
  • Planned extensive travel during study period
  • History of repeated non-attendance at clinic visits

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Greater Los Angeles Healthcare System

North Hills, California, 91343, United States

Location

Related Publications (1)

  • Mak S, Ash G, Liang LJ, Der-McLeod E, Ghadimi S, Kewalramani A, Naeem S, Zeidler M, Fung C. Testing a Consumer Wearables Program to Promote the Use of Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2024 Sep 19;13:e60769. doi: 10.2196/60769.

    PMID: 39207912DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea SyndromesTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHealth BehaviorBehavior

Study Officials

  • Constance H. Fung, MD, MSHS

    VA Greater Los Angeles Healthcare System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 8, 2023

First Posted

September 15, 2023

Study Start

October 20, 2023

Primary Completion

January 21, 2025

Study Completion

January 21, 2025

Last Updated

January 27, 2025

Record last verified: 2025-01

Locations

US(1)