A Validation Study of the NightOwl Home Sleep Apnea Test
Public ClinicalTrials.gov record NCT04764734. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04764734
- Recruitment status
- Not listed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 100 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 13 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 19, 2021
- Primary completion
- Sep 4, 2022
- Completion
- Sep 9, 2022
- Last update posted
- Sep 5, 2022
2021 – 2022
United States locations
- U.S. sites
- 4
- U.S. states
- 1
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Coral Springs Laboratory | Coral Springs | Florida | 33071 | — |
| United Sleep Diagnostics Hollywood Laboratory | Hollywood | Florida | 33021 | — |
| Miami Lakes Laboratory | Miami Lakes | Florida | 33016 | — |
| United Sleep Diagnostics Pembroke Pines Laboratory | Pembroke Pines | Florida | 33024 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04764734, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 5, 2022 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04764734 live on ClinicalTrials.gov.