An interventional study of NightOwl in Sleep Apnea, sponsored by Ectosense NV. Completed at 3 sites in United States. Open to participants aged 13 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-03-30.
Sponsored by Ectosense NV (part of ResMed) · Not applicable, Interventional, and Diagnostic
Among 369 studies in Sleep Apnea Syndromes with a site in United States — 49 open to participants now, 60 under way, 3 of them phase 3. Sleep Apnea Syndromes · United States.
Among the 369 studies in Sleep Apnea Syndromes with a site in United States, this one is the 94th largest by enrollment of the 284 interventional ones that give a count, is one of 22 that started in 2019, is one of 193 with no phase, and was the 264th registered.
1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.
Browse Sleep Apnea Syndromes studies →49 of the 369 studies in Sleep Apnea Syndromes with a site in United States are open now. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
Pfizer · Sites in United States
Pfizer · Sites in United States
VA Office of Research and Development · Sites in United States
Brigham and Women's Hospital · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 117 Sleep Apnea Syndromes studies recruiting now, 57 (49%) set no upper age limit and 36 (31%) stop at 75 or younger; 24 take children under 18; 27 take healthy volunteers.
This study: 13 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
369 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 25 · Phase 2 44 · Phase 3 21 · Phase 4 20
First in 1998; this study’s year is marked. 22 started in 2019.
This study's enrollment of 106 is above the median of 60 across 673 interventional studies indexed under Sleep Apnea Syndromes.
Median enrollment 62 across the 284 interventional studies, 114 across the 82 observational. Of the 268 that completed or were terminated, 134 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
82 of 369 have an industry lead sponsor. The 10 most frequent:
Ectosense NV is the lead sponsor of 6 studies on the registry; none are open to participants now.
Ectosense NV has 4 studies filed under Sleep Apnea Syndromes — fewer than ten, so there is no comparison to draw.
29 of the studies in Sleep Apnea Syndromes with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05382754Children's Hospital of PhiladelphiaHome Apnea Testing in CHildren Trial | 2026-12 |
| NCT05575401Loma Linda UniversityLateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy | 2026-12 |
| NCT02431507Michael HarrisonMagnetic Apnea Prevention(MAGNAP) Device to Treat Obstructive Sleep Apnea:First-In-Human Study of Feasibility and Safety | 2026-12-01 |
| NCT07908199Ouraring Inc.Oura Ring OA15 Validation | 2026-12-03 |
| NCT03278119NYU Langone HealthSleep Aging and Risk for Alzheimer's 2.0 | 2026-12-25 |
Among the 369 studies in Sleep Apnea Syndromes with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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.
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.
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.
| Milestone | PSG and NightOwl |
|---|---|
| Started | 106 |
| Completed | 106 |
| Not completed | 0 |
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.
| Correlation coefficient | PSG and NightOwl |
|---|---|
| Pearson Correlation Between the AHI | 0.909 |
The evaluation of the Pearson correlation between the total sleep time (TST) estimate obtained from the NightOwl and the TST determined from the PSG;
| Correlation coefficient | PSG and NightOwl |
|---|---|
| Pearson Correlation Between the TST | 0.610 |
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.
| Ratio | PSG and NightOwl |
|---|---|
| The Evaluation of the Level of Agreement (Classification Accuracy) Between Patient Categorization | 0.685 |
Collected over Through study completion (during the participant's single-night sleep study). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PSG and NightOwl | 0/106 (0%) | 0/106 (0%) | 0/106 (0%) |
Only participants for which technically adequate polysomnography and home sleep apnea test data was acquired were retained for Baseline Analysis
| Age, Continuous(years) | PSG and NightOwl |
|---|---|
| Mean | 59 ± 15.3 |
| Sex: Female, Male(Participants) | PSG and NightOwl |
|---|---|
| Female | 42 |
| Male | 30 |
| Ethnicity (NIH/OMB)(Participants) | PSG and NightOwl |
|---|---|
| Hispanic or Latino | 39 |
| Not Hispanic or Latino | 33 |
| Unknown or Not Reported | 1 |
| Race/Ethnicity, Customized(Participants) | PSG and NightOwl |
|---|---|
| Race — Black | 18 |
| Race — White | 54 |
| Race — Not reported | 1 |
| Region of Enrollment(participants) | PSG and NightOwl |
|---|---|
| United States | 73 |
| BMI(kg/m^2) | PSG and NightOwl |
|---|---|
| Mean | 32.6 ± 8.2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2019 to primary completion in Feb 2020, 1 month.
Results were first posted in Mar 2021, 1 year 1 month after primary completion.
Of 68 industry-sponsored interventional studies with no phase under Sleep Apnea Syndromes, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 18. This study's 1 month is below that.
Counting every sponsor, half of 268 studies reached it within 26 months; a quarter within 11 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.
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