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A Validation Study of the NightOwl Home Sleep Apnea Test

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04764734
Recruitment Status : Active, not recruiting
First Posted : February 21, 2021
Last Update Posted : September 6, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Device: NightOwl Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group will undergo both gold standard polysomnography (PSG) and NightOwl Sleep Apnea Test
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Validation Study of the NightOwl Home Sleep Apnea Test
Actual Study Start Date : March 20, 2021
Estimated Primary Completion Date : September 5, 2022
Estimated Study Completion Date : September 10, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: PSG and NightOwl
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.
Device: NightOwl
The NightOwl is a finger-mounted home sleep apnea testing device




Primary Outcome Measures :
  1. The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects with an indication for an in-lab polysomnography

Exclusion Criteria:

  • Intellectually disabled people

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04764734


Locations
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United States, Florida
Coral Springs Laboratory
Coral Springs, Florida, United States, 33071
United Sleep Diagnostics Hollywood Laboratory
Hollywood, Florida, United States, 33021
Miami Lakes Laboratory
Miami Lakes, Florida, United States, 33016
United Sleep Diagnostics Pembroke Pines Laboratory
Pembroke Pines, Florida, United States, 33024
Sponsors and Collaborators
Ectosense NV
Investigators
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Principal Investigator: Jagdeep Bijwadia, MD MBA SleepMed RX
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Responsible Party: Ectosense NV
ClinicalTrials.gov Identifier: NCT04764734    
Other Study ID Numbers: NightOwl-02
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: September 6, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases