Back to resultsA Validation Study of the NightOwl Home Sleep Apnea Test
Primary Purpose
Sleep Apnea
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NightOwl
Sponsored by
About this trial
This is an interventional diagnostic trial for Sleep Apnea
Eligibility Criteria
Inclusion Criteria:
- Subjects with an indication for an in-lab polysomnography
Exclusion Criteria:
- Intellectually disabled people
Sites / Locations
- Coral Springs Laboratory
- United Sleep Diagnostics Hollywood Laboratory
- Miami Lakes Laboratory
- United Sleep Diagnostics Pembroke Pines Laboratory
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PSG and NightOwl
Arm Description
During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with the informed consent form. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.
Outcomes
Primary Outcome Measures
The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04764734
Brief Title
A Validation Study of the NightOwl Home Sleep Apnea Test
Official Title
A Validation Study of the NightOwl Home Sleep Apnea Test
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 20, 2021 (Actual)
Primary Completion Date
September 5, 2022 (Anticipated)
Study Completion Date
September 10, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ectosense NV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group will undergo both gold standard polysomnography (PSG) and NightOwl Sleep Apnea Test
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PSG and NightOwl
Arm Type
Experimental
Arm Description
During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with the informed consent form. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam.
Intervention Type
Device
Intervention Name(s)
NightOwl
Intervention Description
The NightOwl is a finger-mounted home sleep apnea testing device
Primary Outcome Measure Information:
Title
The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization
Description
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.
Time Frame
Through study completion, an average of 1 month.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects with an indication for an in-lab polysomnography
Exclusion Criteria:
Intellectually disabled people
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jagdeep Bijwadia, MD MBA
Organizational Affiliation
SleepMed RX
Official's Role
Principal Investigator
Facility Information:
Facility Name
Coral Springs Laboratory
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33071
Country
United States
Facility Name
United Sleep Diagnostics Hollywood Laboratory
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Miami Lakes Laboratory
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
United Sleep Diagnostics Pembroke Pines Laboratory
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Validation Study of the NightOwl Home Sleep Apnea Test
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