Effect of ISABel Bed 1 Ans ISABel Bed 2ISABelNCT04713267
ISABel: Intelligent Sleep Apnoea Bed
A study testing ISABel Bed 1 in people with Effect of ISABel Bed 1 Ans ISABel Bed 2, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Effect of ISABel Bed 1 Ans ISABel Bed 2
- What is being tested?
- ISABel Bed 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 19 Feb 2021to 24 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 influence the position will be investigated:
- 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.
- 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.
- Conditions
- Effect of ISABel Bed 1 Ans ISABel Bed 2
- Being tested
- ISABel Bed 1
- Keywords
- Effect, Comparation, User Feasibility, Tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISABel Bed 1Device
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.
| Study group | Role | What they receive |
|---|---|---|
| ISABel Bed 1 or ISABel Bed 2 | Other | The study has a within-subject repeated measures-design. After a baseline measurement, participants will be allocated to either a first experimental night in automated bed 1 (ISABel Bed 1) and a second one in automated bed 2 (ISABel Bed 2) or a first experimental night in bed 2 and a second one in bed 1. Afterwards, the results of each polysomnographic measurement carried out during the intervention will be compared to the off-treatment baseline measurement. Receives: Device: ISABel Bed 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: three nights
Secondary outcomes (6)
User feasibility of ISABel Bed 1 or ISABel Bed 2
snoring, sleep architecture
Measured: three nights
User effect of ISABel Bed 1 or ISABel Bed 2
total AHI (events/hours), ODI4%, SpO2%, total arousal index (events/hours)
Measured: three nights
User tolerance
morning blood pressure and heart rate
Measured: three nights
Difference ISABel Bed 1 and ISABel Bed 2
in supine AHI between the two beds
Measured: three nights
Assess reliability fo the machine learning algorithms of ISABel Bed 1 and ISABel Bed 2
data collection
Measured: three nights
Safety of ISABel Bed 1 and ISABel Bed 2
Sleep structure and quality
Measured: three nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start19 Feb 2021
- Primary completion24 Jan 2022
- Study completion24 Jan 2022
Why it stopped: Difficulties recruiting participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of ISABel Bed 1 Ans ISABel Bed 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Randomised crossover interventional trial allocating patients with POSA to ISABel Bed 1 or ISABel Bed 2 in random order to study the effect on POSA. Patients with POSA (untreated, or if treated, following a short-term therapy withdrawal) will undergo an in-laboratory polysomnography in ISABel Bed 1 and Bed 2.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04713267
- Sponsor's protocol ID
- ISABel Bed 1 and ISABel Bed 2
- Acronym
- ISABel
- Status last verified
- Feb 2022
- First submitted
- 17 Dec 2020
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ISABel: Intelligent Sleep Apnoea Bed
- ClinicalTrials.gov ID
- NCT04713267
- Acronym / sponsor ID
- ISABel / ISABel Bed 1 and ISABel Bed 2
- Conditions
- Effect of ISABel Bed 1 Ans ISABel Bed 2
- Keywords
- Effect, Comparation, User Feasibility, Tolerance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties recruiting participants
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- University of Zurich
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 24 Jan 2022 (actual)
- Study completion
- 24 Jan 2022 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 influence the position will be investigated:
- 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.
- 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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Randomised crossover interventional trial allocating patients with POSA to ISABel Bed 1 or ISABel Bed 2 in random order to study the effect on POSA. Patients with POSA (untreated, or if treated, following a short-term therapy withdrawal) will undergo an in-laboratory polysomnography in ISABel Bed 1 and Bed 2.
| Arm | Type | Receives |
|---|---|---|
| ISABel Bed 1 or ISABel Bed 2 | Other | Device: ISABel Bed 1The study has a within-subject repeated measures-design. After a baseline measurement, participants will be allocated to either a first experimental night in automated bed 1 (ISABel Bed 1) and a second one in automated bed 2 (ISABel Bed 2) or a first experimental night in bed 2 and a second one in bed 1. Afterwards, the results of each polysomnographic measurement carried out during the intervention will be compared to the off-treatment baseline measurement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISABel Bed 1During 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. | Device | ISABel Bed 1 or ISABel Bed 2 |
Primary outcome
Assessment of the presence of a difference in supine AHI either in ISABel Bed 1 or ISABel Bed 2
Time frame: three nights
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.
6 secondary outcomes
User feasibility of ISABel Bed 1 or ISABel Bed 2
Time frame: three nights
User effect of ISABel Bed 1 or ISABel Bed 2
Time frame: three nights
User tolerance
Time frame: three nights
Difference ISABel Bed 1 and ISABel Bed 2
Time frame: three nights
Assess reliability fo the machine learning algorithms of ISABel Bed 1 and ISABel Bed 2
Time frame: three nights
Safety of ISABel Bed 1 and ISABel Bed 2
Time frame: three nights
Results and safety
The study was stopped early (reason given: Difficulties recruiting participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ISABel Bed 1 in people with Effect of ISABel Bed 1 Ans ISABel Bed 2, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficulties recruiting participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the presence of a difference in supine AHI either in ISABel Bed 1 or ISABel Bed 2 (time frame: three nights). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.