Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test

Study Overview
=================
Brief Summary
-----------------
Extensive Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to traditional PSG and HSAT monitors.

Detailed Description
-----------------
The purpose of this prospective validation study is the evaluation of the accuracy of the NightOwl HSAT to derive parameters relevant for the diagnosis of sleep apnea. The NightOwl HSAT comprises a finger or forehead mounted sensor and an automated analytics software. The sensor measures double-wavelength photo-plethysmography and accelerometry. The analytics software automatically interprets the sensor data and derives a measure of sympathetic activation of the autonomic nervous system, oxygen saturation, instantaneous pulse rate and activity. For each patient in the cohort, the AHI derived by the NightOwl will be compared to that of the Type I sleep monitor (in-lab PSG), which will acquire data simultaneously during the diagnostic night of the patient referred to the sleep lab for a polysomnography. On a randomly selected subset of patients, a benchmark HSAT will additionally be applied for comparison of its automated AHI derivation to that of the NightOwl.

Official Title
-----------------
Extensive Prospective Validation Study of the NightOwl Home Sleep Apnea Test

Conditions
-----------------
Sleep Apnea

Intervention / Treatment
-----------------
* Device: NightOwl HSAT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for a sleep study Exclusion Criteria: Mentally disabled people

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: NightOwl HSAT<br>Patient undergoes a NightOwl sleep apnea test whilst simultaneously undergoing a sleep study with a Type I sleep monitor (Lab-PSG) and optionally a benchmark HSAT monitor. | Device: NightOwl HSAT<br>* Patient wears the NightOwl sensor device<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index (AHI) | Comparison of the AHI derived from the NightOwl HSAT to that of the benchmark PSG and HSAT monitors. | For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep-wake discrimination | Comparison of the sleep-wake discrimination derived from the NightOwl HSAT to that of the benchmark PSG and HSAT monitors. | For each included patient, the outcome measure will be assessed immediately after analysis of that patient's data by the NightOwl HSAT software |