A Validation Study of the NightOwl Home Sleep Apnea Test

NCT04764734 | Unknown FDA Device

• 1 other identifier: NightOwl-02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Sleep Apnea

Outcome Measures

Primary Outcomes (1)

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

  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.

Study Arms (1)

PSG and NightOwl

EXPERIMENTAL

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

Interventions

NightOwl DEVICE

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

PSG and NightOwl

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with an indication for an in-lab polysomnography

You may not qualify if:

• Intellectually disabled people

Sponsors & Collaborators

• Ectosense NV: lead

Study Sites (4)

Coral Springs Laboratory

Coral Springs, Florida, 33071, United States

Location

United Sleep Diagnostics Hollywood Laboratory

Hollywood, Florida, 33021, United States

Location

Miami Lakes Laboratory

Miami Lakes, Florida, 33016, United States

Location

United Sleep Diagnostics Pembroke Pines Laboratory

Pembroke Pines, Florida, 33024, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jagdeep Bijwadia, MD MBA

  SleepMed RX

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Single Group will undergo both gold standard polysomnography (PSG) and NightOwl Sleep Apnea Test

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 21, 2021
• Study Start: March 20, 2021
• Primary Completion: September 5, 2022
• Study Completion: September 10, 2022
• Last Updated: September 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)