Prospective Validation Study of a Novel Type IV Home Sleep Apnea Test
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 450
- Locations
- 1
- Primary Endpoint
- Apnea-Hypopnea Index (AHI)
Study Overview
Brief Summary
Prospective validation study of the NightOwl, a Type IV home sleep apnea test (HSAT), compared to a traditional Type I and a Type IV sleep monitor.
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 Type IV sleep monitor will additionally be applied for comparison of its automated AHI derivation to that of the NightOwl.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Indication for a sleep study
Exclusion Criteria
- •Mentally disabled people
- •Known allergy to Plexiglas (PMMA) or other acrylates
Arms & Interventions
NightOwl HSAT
Patient undergoes a NightOwl sleep apnea test whilst simultaneously undergoing a sleep study with a Type I sleep monitor (Lab-PSG) and optionally a Type IV sleep monitor.
Intervention: NightOwl HSAT (Device)
Outcomes
Primary Outcomes
Apnea-Hypopnea Index (AHI)
Time Frame: At the time of the diagnostic night
Comparison of the AHI derived from the NightOwl HSAT to that of the Type I and Type IV sleep monitors
Secondary Outcomes
- Sleep-wake discrimination(At time of the diagnostic night)