Status:
TERMINATED
ISABel: Intelligent Sleep Apnoea Bed
Lead Sponsor:
Swiss Federal Institute of Technology
Collaborating Sponsors:
University of Zurich
Conditions:
Effect of ISABel Bed 1 Ans ISABel Bed 2
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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 apnoe...
Detailed 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 ...
Eligibility Criteria
Inclusion
- Documented supine positional OSA (AHIsupine/AHInonsupine ≥2) with a total AHI of ≥10 events/hour
- Age ≥18 years and \<80 years
- Written informed consent documented by signature
Exclusion
- Previous or current use of positional therapy
- Use of home oxygen therapy
- Documented hypoventilation syndrome
- Documented Cheyne-Stokes breathing
- Documented moderate-to-severe or severe obstructive lung diseases
- Chronic heart failure
- Documented active drug or alcohol abuse
- Known or suspected non-compliance
- Inability to follow the procedures of the study, e.g. due to language problems, documented psychological disorders, documented dementia, etc. of the participant
- Current professional driver or any either documented or reported previous sleep-related driving accidents
- People working with or operating heavy machinery
- Child-bearing age: female participants who are neither surgically sterilised / hysterectomised nor post-menopausal for longer than 2 years are considered as being of child bearing potential
- Documented unstable, untreated coronary or peripheral artery disease, severe hypertension or hypotension (≥180/110 or ≤90/60 mmHg)
- BMI \>40 kg/m2 or body weight \>130 kg
- Being the investigator, his/her family members, employees, or other dependent persons
Key Trial Info
Start Date :
February 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 24 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04713267
Start Date
February 19 2021
End Date
January 24 2022
Last Update
February 28 2022
Active Locations (1)
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1
ETH Zurich
Zurich, Switzerland, 8000