NCT04597749

Brief Summary

This is a prospective, unblinded, open-label, single group study. All subjects will undergo concurrent screener app, HSAT testing, and in-lab polysomnography.

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 2020

Shorter than P25 for not_applicable

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

August 31, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 22, 2020

Completed
5 days until next milestone

Study Start

First participant enrolled

October 27, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
Last Updated

February 4, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

August 31, 2020

Last Update Submit

February 1, 2021

Conditions

Sleep Apnea, Obstructive

Keywords

OSASleep ApneaOSA ScreenersHome Sleep Apnea Test

Outcome Measures

Primary Outcomes (1)

  • AHI value. Clinical decision for treatment output (Y to CPAP or N to CPAP) of Screener apps and HSAT compared to PSG.

    The PSG clinical decision for treatment is defined as AHI≥15. Screener apps and HSATs provide AHI values that will be used for comparison.

    Day 1

Secondary Outcomes (1)

  • OSA severity categories (normal, mild, moderate, severe) of Screnner apps and HSAT compared to PSG.

    Day 1

Study Arms (1)

Concurrent PSG, HSAT, and Screener App Test

EXPERIMENTAL

Participants will undergo a single night baseline PSG test with concurrent HSAT tests as well as non-contact screening mobile apps through a smartphone.

Diagnostic Test: PSGDiagnostic Test: Home Sleep Apnea Test with FDA cleared devicesOther: Non-Contact Screening App

Interventions

PSGDIAGNOSTIC_TEST

In-lab sleep polysomnography test

Concurrent PSG, HSAT, and Screener App Test
Home Sleep Apnea Test with FDA cleared devicesDIAGNOSTIC_TEST

In-lab HST test

Concurrent PSG, HSAT, and Screener App Test
Non-Contact Screening AppOTHER

Non-Contact Sleep Apnea Screening Applications at bedside table to assess for sleep apnea.

Concurrent PSG, HSAT, and Screener App Test

Eligibility Criteria

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

You may qualify if:

  • Participant is 18 years of age or older
  • Participant is willing to provide informed consent
  • Participant is willing to participate in all study related procedures

You may not qualify if:

  • Unable to cease PAP therapy during PSG (if currently using)
  • Requires use of oxygen therapy during sleep
  • Diagnosis of untreated clinically relevant sleep disorder (other than SDB)
  • Pregnant
  • Participant is unsuitable to participate in the study in the opinion of the investigator
  • Participant has a permanent pacemaker, sustained non-sinus cardiac arrhythmias, and/or takes alpha blocker or short acting nitrate medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clayton Sleep Institute

Maplewood, Missouri, 63143, United States

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Design

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

Study Record Dates

First Submitted

August 31, 2020

First Posted

October 22, 2020

Study Start

October 27, 2020

Primary Completion

December 31, 2020

Study Completion

January 20, 2021

Last Updated

February 4, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)