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A Validation Study of the NightOwl Home Sleep Apnea Test

N/A

Waitlist Available

Led By Jagdeep Bijwadia, MD MBA

Research Sponsored by Ectosense NV

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* Subjects with an indication for an in-lab polysomnography

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 1 month.

Awards & highlights

No Placebo-Only Group

Summary

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.

Eligible Conditions

Sleep Apnea

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 1 month.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 1 month.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 month. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PSG and NightOwlExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NightOwl

2019

N/A

~240

0 / 1Eligibility criteria met