Trials / Unknown
UnknownNCT05376475
Sleep in Late Pregnancy - Artificial Intelligence Development for the Detection of Disturbances and Disorders
Sleep in Late Pregnancy - Artificial Intelligence Development for the Detection of Disturbances and Disorders (SLeeP AID4): An Observational, In-Home, Single-Group, Feasibility Study
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 60 (estimated)
- Sponsor
- Shiphrah Biomedical Inc. · Industry
- Sex
- All
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Accepted
Summary
SLeeP AID4 is a single-group, single-arm, Canada-wide, non-randomised, unblinded, in-home, observational study to prospectively collect and build a data set of natural sleep behaviour and physiology in maternal-fetal dyads (and bed partners, if applicable) in the third trimester of pregnancy in the home setting and subsequently investigate the feasibility of using computer vision technology (CVT) to monitor sleep during and across the third trimester of pregnancy in the home setting for research purposes by eliciting participants' attitudes toward CVT and training, validating, and testing a CVT model to accurately, unobtrusively, non-invasively, and objectively detect and quantify various sleep behaviours, disturbances, and disorders.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Infrared video-audio camera | Wyze Cam V2 by Wyze Labs, Inc., Seattle, USA |
| DEVICE | Level III home sleep apnea test | NightOwl® by Ectosense, Leuven, Belgium |
| DEVICE | Maternal-fetal transabdominal electrocardiographic heart rate monitor | The Monica AN24 Antenatal Fetal Holter by Monica Healthcare, Nottingham, UK |
| DEVICE | Pressure sensing mat | Tactilus® V Series Mattress Pressure Monitoring System by Sensor Products Inc., Madison, USA |
Timeline
- Start date
- 2022-07-06
- Primary completion
- 2023-06-30
- Completion
- 2024-06-30
- First posted
- 2022-05-17
- Last updated
- 2022-10-28
Locations
1 site across 1 country: Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05376475. Inclusion in this directory is not an endorsement.