A Validation Study of the NightOwl Home Sleep Apnea Test

September 2, 2022 updated by: Ectosense NV
The objective of this study is to evaluate the performance of a miniaturized sleep apnea test, called NightOwl. The system consists of a sensor placed on the fingertip and a cloud-based analytics software. The sensor acquires accelerometer and photoplethysmographic data. The software derives actigraphy from the former, and blood oxygen saturation and peripheral arterial tone (PAT), among other features, from the latter. In order to assess NightOwl's performance, the investigators will compare the apnea hypopnea index (AHI) estimate, defined as the number of respiratory events per hour of sleep, derived by the NightOwl system, to the apnea-hypopnea index (AHI) obtained from manual analysis of the polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. This study will be performed in a sleep lab environment.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Coral Springs, Florida, United States, 33071
        • Coral Springs Laboratory
      • Hollywood, Florida, United States, 33021
        • United Sleep Diagnostics Hollywood Laboratory
      • Miami Lakes, Florida, United States, 33016
        • Miami Lakes Laboratory
      • Pembroke Pines, Florida, United States, 33024
        • United Sleep Diagnostics Pembroke Pines Laboratory

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with an indication for an in-lab polysomnography

Exclusion Criteria:

  • Intellectually disabled people

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PSG and NightOwl
During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with the informed consent form. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.
Device: NightOwl
The NightOwl is a finger-mounted home sleep apnea testing device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization
Time Frame: Through study completion, an average of 1 month.
The evaluation of the level agreement (classification accuracy) between patient categorization (into sleep apnea severity categories) obtained by the NightOwl and those obtained by the PSG. This measure is calculated by dividing the number of participants on which both NightOwl and the PSG agree on the sleep apnea severity category by the total number of participants.
Through study completion, an average of 1 month.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ectosense NV

Investigators

  • Principal Investigator: Jagdeep Bijwadia, MD MBA, SleepMed RX

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2021

Primary Completion (Anticipated)

September 5, 2022

Study Completion (Anticipated)

September 10, 2022

Study Registration Dates

First Submitted

February 18, 2021

First Submitted That Met QC Criteria

February 18, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

September 6, 2022

Last Update Submitted That Met QC Criteria

September 2, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NightOwl-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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