A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test

• Sponsor: Ectosense NV (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04191668
• Collaborator: (none)
• Enrollment: 106
• Locations: 3
• Arm: 1
• Actual Duration (Months): 2
• Patients Per Site: 35.3
• Patients Per Site Per Month: 17.6

Study Details

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 respiratory event index (REI), 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. The investigators will also compare the total sleep time (TST) derived by both systems. This study will be performed in a sleep lab environment.

Condition or Disease	Intervention/Treatment	Phase
Sleep Apnea	Device: NightOwl	N/A

Detailed Description

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 respiratory event index (REI), defined as the number of respiratory events per hour of sleep, derived by the NightOwl system, to the AHI obtained from manual analysis of the polysomnography (PSG), which is the gold standard for sleep apnea diagnosis. The investigators will also compare the total sleep time (TST) derived by both systems. This study will be performed in a sleep lab environment.

As of March 2017, the new clinical practice guideline for diagnostic testing for adult sleep apnea of the American Academy of Sleep Medicine (AASM) for the first time formulates a strong recommendation that both polysomnography (PSG) and home sleep apnea testing (HSAT) are appropriate diagnostic testing options for uncomplicated adult patients who are at increased risk of moderate to severe sleep apnea.

Collop et al. performed a comprehensive analysis of the evidence for HSAT devices to diagnose obstructive sleep apnea (OSA) in out-of-center settings. The authors concluded that testing devices that analyze changes in peripheral arterial tone (PAT) in combination with actigraphy and blood oxygen saturation (SpO2) are adequate to diagnose OSA in patient populations with a high pre-test probability.

In this study, the investigators wish to assess the performance of a system for the diagnosis of OSA that measures and analyzes the abovementioned parameters, called NightOwl. The system consists of a small sensor device which is placed on the fingertip and a cloud-based analytics platform.

It is designed to be self-applied and initiated by the patient by attaching the sensor to the fingertip by means of an adhesive patch.

Study Design

• Study Type: Interventional
• Actual Enrollment: 106 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 TestSingle Group will undergo both gold standard polysomnography (PSG) and NightOwl Sleep Apnea Test
• Masking: None (Open Label)
• Masking Description: Sleep technician which analyses the PSG data will be blinded from any prior PSG analysis and the NightOwl analysis
• Primary Purpose: Diagnostic
• Official Title: A Validation Study of the NightOwl PAT-based Home Sleep Apnea Test
• Actual Study Start Date: Dec 2, 2019
• Actual Primary Completion Date: Feb 1, 2020
• Actual Study Completion Date: Feb 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: PSG and NightOwl Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. 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

Outcome Measures

Primary Outcome Measures

1. Pearson Correlation Between the AHI [Through study completion, an average of 1 month.]

   The evaluation of the Pearson correlation between the apnea-hypopnea index (AHI) estimate obtained from the NightOwl and the AHI determined from the polysomnography (PSG); The AHI is defined as the number of apnea or hypopnea divided by the (estimated) total sleep time expressed in hours.

2. Pearson Correlation Between the TST [Through study completion, an average of 1 month.]

   The evaluation of the Pearson correlation between the total sleep time (TST) estimate obtained from the NightOwl and the TST determined from the PSG;

3. The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 13 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects with an indication for an in-lab polysomnography

Exclusion Criteria:

• Intellectually disabled people

• People younger than 13 years of age.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Miami Lakes Laboratory	Miami Lakes	Florida	United States	33016
2	Plantation Laboratory East	Plantation	Florida	United States	33324
3	Plantation Laboratory West	Plantation	Florida	United States	33324

Sponsors and Collaborators

• Ectosense NV

Investigators

• Study Director: Frederik Massie, MSc, Ectosense NV

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jan 5, 2020

More Information

Publications

None provided.

• Responsible Party: Ectosense NV
• ClinicalTrials.gov Identifier: NCT04191668
• Other Study ID Numbers: NightOwl-01
• First Posted: Dec 10, 2019
• Last Update Posted: Mar 30, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Apnea; Sleep Apnea Syndromes

Study Results

Participant Flow

Arm/Group Title	PSG and NightOwl
Arm/Group Description	Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam. NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device
Period Title: Overall Study
STARTED	106
COMPLETED	106
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	PSG and NightOwl
Arm/Group Description	Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam. NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device
Overall Participants	73
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	59 (15.3)
Sex: Female, Male (Count of Participants)
Female	42 57.5%
Male	30 41.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	39 53.4%
Not Hispanic or Latino	33 45.2%
Unknown or Not Reported	1 1.4%
Race/Ethnicity, Customized (Count of Participants)
Black	18 24.7%
White	54 74%
Not reported	1 1.4%
Region of Enrollment (participants) [Number]
United States	73 100%
BMI (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	32.6 (8.2)

Outcome Measures

1. Primary Outcome

Title	Pearson Correlation Between the AHI
Description	The evaluation of the Pearson correlation between the apnea-hypopnea index (AHI) estimate obtained from the NightOwl and the AHI determined from the polysomnography (PSG); The AHI is defined as the number of apnea or hypopnea divided by the (estimated) total sleep time expressed in hours.
Time Frame	Through study completion, an average of 1 month.

Outcome Measure Data

Analysis Population Description

The population comprised those participants for which technically adequate polysomnography and home sleep apnea test data could be acquired.

Arm/Group Title	PSG and NightOwl
Arm/Group Description	Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam. NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device
Measure Participants	73
Number [Correlation coefficient]	0.909

2. Primary Outcome

Title	Pearson Correlation Between the TST
Description	The evaluation of the Pearson correlation between the total sleep time (TST) estimate obtained from the NightOwl and the TST determined from the PSG;
Time Frame	Through study completion, an average of 1 month.

Outcome Measure Data

Analysis Population Description

The population comprised those participants for which technically adequate polysomnography and home sleep apnea test data could be acquired.

Arm/Group Title	PSG and NightOwl
Arm/Group Description	Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam. NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device
Measure Participants	73
Number [Correlation coefficient]	0.610

3. Primary Outcome

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.

Outcome Measure Data

Analysis Population Description

The population comprised those participants for which technically adequate polysomnography and home sleep apnea test data could be acquired.

Arm/Group Title	PSG and NightOwl
Arm/Group Description	Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam. NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device
Measure Participants	73
Number [Ratio]	0.685

Adverse Events

Time Frame	Through study completion (during the participant's single-night sleep study)
Arm/Group Title	PSG and NightOwl
Arm/Group Description	Default patient recruitment During the study, for each execution day, all patients that have been scheduled for a PSG will be presented with an informed consent. All recruited patients shall be a part of the study during which they wear the NightOwl Sensor while undergoing the PSG exam. NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device
All Cause Mortality
	PSG and NightOwl
	Affected / at Risk (%)	# Events
Total	0/106 (0%)
Serious Adverse Events
	PSG and NightOwl
	Affected / at Risk (%)	# Events
Total	0/106 (0%)
Other (Not Including Serious) Adverse Events
	PSG and NightOwl
	Affected / at Risk (%)	# Events
Total	0/106 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.