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A Validation Study of the NightOwl Home Sleep Apnea Test

Not Applicable
Active, not recruiting
Conditions
Sleep Apnea
Registration Number
NCT04764734
Lead Sponsor
Ectosense NV
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
100
Inclusion Criteria
  • Subjects with an indication for an in-lab polysomnography
Exclusion Criteria
  • Intellectually disabled people

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient CategorizationThrough 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (4)

Coral Springs Laboratory

🇺🇸

Coral Springs, Florida, United States

United Sleep Diagnostics Hollywood Laboratory

🇺🇸

Hollywood, Florida, United States

Miami Lakes Laboratory

🇺🇸

Miami Lakes, Florida, United States

United Sleep Diagnostics Pembroke Pines Laboratory

🇺🇸

Pembroke Pines, Florida, United States

Coral Springs Laboratory
🇺🇸Coral Springs, Florida, United States

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