Trials / Completed
CompletedNCT03823105
Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages
Validation of Non-invasive Miniature Optical Sensors for Scoring Sleep Stages: a Prospective, Method-comparison, Proof of Concept, Single-centre Phase IV Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- Insel Gruppe AG, University Hospital Bern · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Accepted
Summary
Validation of two devices with optical sensor in healthy participants and patients with sleep wake disorders.
Detailed description
The objective of this study is to evaluate and optimize a method of detecting sleep and sleep stages based on a new algorithm combining actigraphy and heart rate variability (measured by optical analysis of the pulse wave) to determine sleep architecture (segmented into three phases: WAKE, REM and NREM) with high accuracy compared to the gold standard polysomnography.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | OHR Tracker and PulseWatch | Category A (ClinO). Medical study with CE-marked medical devices to photoplethysmographic measure heart rate, heart rate variability, and pulse wave and accelerometric data |
Timeline
- Start date
- 2018-12-06
- Primary completion
- 2020-04-01
- Completion
- 2020-06-10
- First posted
- 2019-01-30
- Last updated
- 2020-06-11
Locations
1 site across 1 country: Switzerland
Source: ClinicalTrials.gov record NCT03823105. Inclusion in this directory is not an endorsement.