A Validation Study of the NightOwl Home Sleep Apnea Test

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04764734

Enrollment

100

Registered

2021-02-21

Start date

2021-03-20

Completion date

2022-09-10

Last updated

2022-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea

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.

Interventions

DEVICENightOwl

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

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

Eligibility

Sex/Gender

ALL

Age

13 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Subjects with an indication for an in-lab polysomnography

Exclusion criteria

* Intellectually disabled people

Design outcomes

Primary

Measure	Time frame	Description
The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026