NCT04249011

Brief Summary

Subjects who consent to participate in the research will undergo a simultaneous recording of inlab PSG and WatchPAT200 for comparing the WatchPAT data to PSG at an altitude of 8500'.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2018

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

Study Start

First participant enrolled

May 2, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 14, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 20, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 30, 2020

Completed
Last Updated

January 30, 2020

Status Verified

January 1, 2020

Enrollment Period

3 months

First QC Date

January 20, 2020

Last Update Submit

January 29, 2020

Conditions

Sleep Disorder; Breathing-Related

Outcome Measures

Primary Outcomes (1)

  • Comparison of AHI and ODI as scored automatically by the WatchPAT compared to manual scoring of full night PSG.

    8 months.

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects referred to a sleep lab for full PSG.

You may qualify if:

  • Male and females ≥ age 17yrs
  • Subject is able to read understand and sign the informed consent form.
  • Willing to sleep with the WP200U and PSG simultaneously in the sleep lab.

You may not qualify if:

  • Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study).
  • Any condition that in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient ability to complete the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mountain Sleep Diagnostics

Woodland Park, Colorado, 80863, United States

Location

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Koby Sheffy, Phd

    Itamar-Medical, Israel

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2020

First Posted

January 30, 2020

Study Start

May 2, 2018

Primary Completion

August 14, 2018

Study Completion

December 10, 2019

Last Updated

January 30, 2020

Record last verified: 2020-01

Locations

US(1)