A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test

NCT ID: NCT04191668

Last Updated: 2021-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 106 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-02
• Study Completion Date: 2020-02-01

Brief 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 respiratory event index (REI), 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. The investigators will also compare the total sleep time (TST) derived by both systems. This study will be performed in a sleep lab environment.

Detailed Description

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 respiratory event index (REI), defined as the number of respiratory events per hour of sleep, derived by the NightOwl system, to the AHI obtained from manual analysis of the polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. The investigators will also compare the total sleep time (TST) derived by both systems. This study will be performed in a sleep lab environment.

As of March 2017, the new clinical practice guideline for diagnostic testing for adult sleep apnea of the American Academy of Sleep Medicine (AASM) for the first time formulates a strong recommendation that both polysomnography (PSG) and home sleep apnea testing (HSAT) are appropriate diagnostic testing options for uncomplicated adult patients who are at increased risk of moderate to severe sleep apnea.

Collop et al. performed a comprehensive analysis of the evidence for HSAT devices to diagnose obstructive sleep apnea (OSA) in out-of-center settings. The authors concluded that testing devices that analyze changes in peripheral arterial tone (PAT) in combination with actigraphy and blood oxygen saturation (SpO2) are adequate to diagnose OSA in patient populations with a high pre-test probability.

In this study, the investigators wish to assess the performance of a system for the diagnosis of OSA that measures and analyzes the abovementioned parameters, called NightOwl. The system consists of a small sensor device which is placed on the fingertip and a cloud-based analytics platform.

It is designed to be self-applied and initiated by the patient by attaching the sensor to the fingertip by means of an adhesive patch.

Conditions

Sleep Apnea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PSG and NightOwl

Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.

Group Type: OTHER

NightOwl

Intervention Type: DEVICE

The NightOwl is a finger-mounted home sleep apnea testing device

Interventions

NightOwl

The NightOwl is a finger-mounted home sleep apnea testing device

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects with an indication for an in-lab polysomnography

Exclusion Criteria

• Intellectually disabled people
• People younger than 13 years of age.

• Minimum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ectosense NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederik Massie, MSc

Role: STUDY_DIRECTOR

Ectosense NV

Locations

Miami Lakes Laboratory

Miami Lakes, Florida, United States

Plantation Laboratory East

Plantation, Florida, United States

Plantation Laboratory West

Plantation, Florida, United States

Countries

United States

References

Massie F, Vits S, Verbraecken J, Bergmann J. Context-aware analysis enhances autoscoring accuracy of home sleep apnea testing. J Clin Sleep Med. 2025 May 1;21(5):789-804. doi: 10.5664/jcsm.11534.

Reference Type: DERIVED

PMID: 39748512 (View on PubMed)

Van Pee B, Massie F, Vits S, Dreesen P, Klerkx S, Bijwadia J, Verbraecken J, Bergmann J. A multicentric validation study of a novel home sleep apnea test based on peripheral arterial tonometry. Sleep. 2022 May 12;45(5):zsac028. doi: 10.1093/sleep/zsac028. Epub 2022 Feb 2.

Reference Type: DERIVED

PMID: 35554589 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NightOwl-01

Identifier Type: -

Identifier Source: org_study_id