---
title: Validation of a Contactless Vital Signs Measurement Sensor
nct_id: NCT04676191
overall_status: COMPLETED
phase: NA
sponsor: Sleepiz AG
study_type: INTERVENTIONAL
primary_condition: Sleep Apnea
countries: Switzerland
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04676191.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04676191"
ct_last_update_post_date: 2022-01-25
last_seen_at: "2026-05-12T06:51:59.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Validation of a Contactless Vital Signs Measurement Sensor

**Official Title:** Single- Center Performance Assessment of a Contactless Sensor for Vital Physiological Parameters Measurement at Rest and Detection of Diagnostic Indices in Sleep Compared to Cardiorespiratory Polygraphy

**NCT ID:** [NCT04676191](https://clinicaltrials.gov/study/NCT04676191)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 64
- **Lead Sponsor:** Sleepiz AG
- **Conditions:** Sleep Apnea
- **Start Date:** 2020-09-10
- **Completion Date:** 2022-01-12
- **CT.gov Last Update:** 2022-01-25

## Brief Summary

The primary aim of this study is to validate the performance of Sleepiz One+ for the measurement of vital physiological parameters in adult population, against a laboratory-based polysomnography. Additionally, the investigators will evaluate Sleepiz One+ ability to identify patients with a high risk of suffering from a sleep-related breathing disorder based on apnea-hypopnea index estimation. Participants will undergo measurement with Sleepiz One+ and a polysomnography device while resting in bed for 20 min as well as during sleep for the duration of the following night.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Age \>18years
* Ability and consent to undergo electrophysiological routine assessment
* Informed Consent as documented by signature
* Patients diagnosed or suspected to suffer from sleep apnea or any other sleep related disorder or patients suffering from chronic cardiac, respiratory or neuromuscular disorders
* Ambulatory or stationary patients of Klinik Lengg

Exclusion Criteria:

* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Cardiac pacemaker or another implanted electrical device
* Women who are pregnant
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant
```

## Arms

- **Patients with sleep disorders, cardiorespiratory or neuromuscular disorders** (EXPERIMENTAL)

## Interventions

- **Sleepiz One+** (DEVICE) — Simultaneous sleep study with polysomnography and Sleepiz One+
- **Polysomnography** (DEVICE) — Simultaneous sleep study with polysomnography and Sleepiz One+

## Primary Outcomes

- **Respiration rate measurement accuracy agreement** _(time frame: 60 seconds)_

## Secondary Outcomes

- **Binary classification of sleep apnea severity based on the AHI > 15 of Sleepiz One+ compared to results of Domino software and data manually scored by sleep technician** _(time frame: 1 Night)_
- **Instantaneous respiration rate agreement between Sleepiz One+ and nasal cannula** _(time frame: 60 seconds)_
- **Average respiration rate agreement between Sleepiz One+ and thoracic respiratory effort belt** _(time frame: 1 Night)_
- **Average respiration rate agreement between Sleepiz One+ and nasal cannula** _(time frame: 1 Night)_
- **Sleep/wake classification agreement between Sleepiz One+ compared to polysomnography (PSG) data manually scored by sleep technician** _(time frame: 60 seconds)_

## Locations (1)

- Klinik Lengg AG, Zurich, Switzerland

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.klinik lengg ag|zurich||switzerland` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT04676191.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT04676191*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*