Clinical trial NCT04191668: A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test
Official title: A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea
Lead sponsor: Ectosense NV
Sponsor class: INDUSTRY
First posted: 2019-12-10
Enrollment: 106
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group will undergo both gold standard polysomnography (PSG) and NightOwl Sleep Apnea Test
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Pearson Correlation Between the AHI
timeFrame: Through study completion, an average of 1 month.
measure: Pearson Correlation Between the TST
timeFrame: Through study completion, an average of 1 month.
measure: The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization
timeFrame: Through study completion, an average of 1 month.
Secondary outcomes:
Other outcomes:
Locations:
city: Miami Lakes
country: United States
facility: Miami Lakes Laboratory
state: Florida
city: Plantation
country: United States
facility: Plantation Laboratory East
state: Florida
city: Plantation
country: United States
facility: Plantation Laboratory West
state: Florida
Study officials:
affiliation: Ectosense NV
name: Frederik Massie, MSc
role: STUDY_DIRECTOR
References:
citation: 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.