Sleep Apnea
Conditions
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.
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.
Interventions
DEVICENightOwl
The NightOwl is a finger-mounted home sleep apnea testing device
Sponsors
Ectosense NV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Sleep technician which analyses the PSG data will be blinded from any prior PSG analysis and the NightOwl analysis
Intervention model description
Single Group will undergo both gold standard polysomnography (PSG) and NightOwl Sleep Apnea Test
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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; |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
NightOwl: The NightOwl is a finger-mounted home sleep apnea testing device | 73 |
| Total | 73 |
Baseline characteristics
| Characteristic | PSG and NightOwl |
|---|---|
| Age, Continuous | 59 years STANDARD_DEVIATION 15.3 |
| BMI | 32.6 kg/m^2 STANDARD_DEVIATION 8.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race/Ethnicity, Customized Race Black | 18 Participants |
| Race/Ethnicity, Customized Race Not reported | 1 Participants |
| Race/Ethnicity, Customized Race White | 54 Participants |
| Region of Enrollment United States | 73 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 30 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 106 |
| other Total, other adverse events | 0 / 106 |
| serious Total, serious adverse events | 0 / 106 |
Outcome results
Primary
Pearson Correlation Between the AHI
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.
Population: The population comprised those participants for which technically adequate polysomnography and home sleep apnea test data could be acquired.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PSG and NightOwl | Pearson Correlation Between the AHI | 0.909 Correlation coefficient |
Primary
Pearson Correlation Between the TST
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.
Population: The population comprised those participants for which technically adequate polysomnography and home sleep apnea test data could be acquired.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PSG and NightOwl | Pearson Correlation Between the TST | 0.610 Correlation coefficient |
Primary
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.
Time frame: Through study completion, an average of 1 month.
Population: The population comprised those participants for which technically adequate polysomnography and home sleep apnea test data could be acquired.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PSG and NightOwl | The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization | 0.685 Ratio |