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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04713267
Other study ID # ISABel Bed 1 and ISABel Bed 2
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date February 19, 2021
Est. completion date January 24, 2022

Study information

Verified date February 2022
Source Swiss Federal Institute of Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this trial is to assess the effect of two automated beds on severity of POSA as well as the feasibility of these beds as POSA treatment. These beds are equipped with sensors detecting apnoeas and hypopnoeas from physiological measurements - such as chest movement or breathing sound -, and coherently reacting by actively changing the user position whenever an apnoeic event occurs. Thereby we will investigate a possible treatment alternative to already established OSA therapies, either as a valuable add-on for patients eligible to the currently available therapies or as primary treatment option.


Description:

During the intervention nights (2 out of 3 experiment nights), positional therapy by means of the automated bed will be applied in order to induce a change in the sleeping position. Two approaches to influence the position will be investigated: 1. Lifting the upper body up, which has been suggested as a method for reducing habitual snoring. This intervention will be provided by an adjustable bed (AmbianceE-Motion, manufactured by Elite SA, Aubonne, Switzerland) referred to as ISABel Bed 1. This bed contains four motors for changing the inclination angle of the head, trunk, leg, and foot support. Only the position of the trunk and head support is changed during the study. The inclination angle is set to the maximum inclination angle the bed allows: this is 50° at the slatted frame which results in approximately 40° inclination of the hip of the user. The reference angle (0°) is represented by the supine position. 2. Inclination of one side of the bed. This intervention will be provided with a custom-made, adjustable bed base prototype, referred to as ISABel Bed 2 (produced by Sensory-Motor Systems Lab, ETH Zurich, Zurich, Switzerland). The bed is equipped with two motors which allow sideward inclination of up to 40 °. The inclination to be applied in this study is set to 30 ° based on a pre-study with healthy human subjects. Both beds are equipped with non-invasive, cable-free sensors (cardio-ballistography, microphone, and force sensor). A closed-loop control algorithm, which has been developed using machine learning techniques, continuously monitors these signals and triggers the positional intervention, when it detects that the participant is experiencing an apnoea event.


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Study Design


Related Conditions & MeSH terms


Intervention

Device:
ISABel Bed 1
During the intervention nights (2 out of 3 experiment nights), positional therapy by means of the automated bed will be applied in order to induce a change in the sleeping position.

Locations

Country Name City State
Switzerland ETH Zurich Zurich

Sponsors (2)

Lead Sponsor Collaborator
Swiss Federal Institute of Technology University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of the presence of a difference in supine AHI either in ISABel Bed 1 or ISABel Bed 2 The primary outcome will be the presence of a difference in supine AHI (events/hour) between the control bed (polysomnography - PSG- on Day 6) and either ISABel Bed 1 or ISABel Bed 2 (respectively on Day 7 and Day 8 to 14, depending on the randomisation order). AHI supine refers to the part of the total AHI that is caused by lying in supine position. This index is per definition twice as much as the non-supine AHI in patients with POSA. The intervention should reduce the time spent in supine position and therefore reduce the supine AHI. three nights
Secondary User feasibility of ISABel Bed 1 or ISABel Bed 2 snoring, sleep architecture three nights
Secondary User effect of ISABel Bed 1 or ISABel Bed 2 total AHI (events/hours), ODI4%, SpO2%, total arousal index (events/hours) three nights
Secondary User tolerance morning blood pressure and heart rate three nights
Secondary Difference ISABel Bed 1 and ISABel Bed 2 in supine AHI between the two beds three nights
Secondary Assess reliability fo the machine learning algorithms of ISABel Bed 1 and ISABel Bed 2 data collection three nights
Secondary Safety of ISABel Bed 1 and ISABel Bed 2 Sleep structure and quality three nights