NCT05112757

Brief Summary

This study aims to guide participants in recognizing their OSA (obstructive sleep apnea) and AFib (atrial fibrillation) symptoms, realizing what medical conditions can cause these symptoms (if any) and inform the participants on their possible diagnosis

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

October 19, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

November 9, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

February 24, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2022

Completed
Last Updated

December 12, 2022

Status Verified

December 1, 2022

Enrollment Period

10 months

First QC Date

October 19, 2021

Last Update Submit

December 8, 2022

Conditions

Obstructive Sleep ApneaAtrial Fibrillation

Keywords

OSAAFib

Outcome Measures

Primary Outcomes (1)

  • Effective conversion

    Number of patients that visited the Primary Care Physician

    6 months after consent

Study Arms (1)

Intervention

EXPERIMENTAL

Smartphone app use

Other: Smartphone application use

Interventions

Smartphone application useOTHER

Use of a smartphone application

Intervention

Eligibility Criteria

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

You may qualify if:

  • High risk of OSA and/or AFib, as defined by the risk algorithm developed by Sanford health
  • years or older, with sufficient English language skills
  • Owning a smartphone with a relatively new operating system (iOS v. 14 (Iphone 6S or higher) or an Android device v.11\<)
  • Able to download and handle an app on a smartphone
  • Willing and able to give informed consent

You may not qualify if:

  • Diagnosed with OSA and/or AFib
  • Diagnosed health issues that are potentially life threatening or causing mental issues (stroke, Alzheimer's Disease, depression, etc.)
  • Pregnancy/breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandford Health

Sioux Falls, South Dakota, 57105, United States

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveAtrial Fibrillation

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Tim Weysen, MSc

    Philips Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2021

First Posted

November 9, 2021

Study Start

February 24, 2022

Primary Completion

December 8, 2022

Study Completion

December 8, 2022

Last Updated

December 12, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)