Sleep ApneaNCT04265118
Sideward Turning Beds for Sleep Apnea
A study testing Sidewards Tilting Bed in people with Sleep Apnea, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
The aim of this feasibility study is to compare different settings of a custom-made automated bed with respect to their ability to induce a change in the sleeping position of the user. In particular, it is of interest whether the bed mechanism is able to change the position of a user from supine to lateral position. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Apnea
- What is being tested?
- Sidewards Tilting Bed
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 10 Mar 2020to 19 Jul 2020
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 12.5 % of the sleep in the screening night spent in supine position.
Who cannot join
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Injuries or pain that prevents sleeping in supine or lateral position.
- Pregnancy.
- Length longer than 2 m (larger than standard bed).
- investigators, their family members, employees and other dependent persons^.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Sideward Turning Beds to Treat Positional Obstructive Sleep Apnea
The aim of this feasibility study is to compare different settings of a custom-made automated bed with respect to their ability to induce a change in the sleeping position of the user. In particular, it is of interest whether the bed mechanism is able to change the position of a user from supine to lateral position. At the same time, the investigators want to know whether the intervention provided by the bed results in an arousal in sleeping users. In addition, feasibility of detecting the position of the user using the un-obtrusive pressure sensors, which are integrated in the bed, will be assessed.
Within the experiment, the investigators will identify participants that are sleeping mainly in supine position by doing an acti-watch based screening measurement in their home setting. Those participants who are sleeping in supine position for more than 12.5% of the home recording with the acti-watch will be invited to come to the lab for one night measurement. The experimenter will trigger interventions of the bed manually when the participant is lying in supine position. The investigators will evaluate the position change using infrared cameras and the built in sensors of the bed. Furthermore, a commercially available home-measurement device to record polysomnography will be used to evaluate whether the intervention caused arousals.
Read the detailed description
Obstructive positional sleep apnea
Obstructive sleep apnea (OSA) is characterised by a repetitive collapse of the upper airway during sleep, which results in apnea or hypopnoea associated with oxygen desaturations and arousals. OSA affects up to 30% of the adult male population, increases with age, and is associated with daytime sleepiness, increased risk of traffic accidents, arterial hypertension, vascular dysfunction and cardiovascular events. In 56% to 75% percent of these apnea patients, the apnea-hypopnea index is correlating with the body position. This subgroup of patients suffers from position-dependent sleep apnea, which is defined by a difference in the apnea hypopnea index between supine position and non-supine positions of at least 50%. Current treatment recommendation for OSA is continuous positive airway pressure (CPAP) ventilation, because of its potential beneficial impact on cardiovascular outcomes. However, a recent randomised controlled trial has not shown reduction in major cardiovascular endpoints in OSA patients with manifest cardiovascular disease allocated to CPAP. Therefore, the beneficial effect of CPAP treatment has been subject to extensive discussion recently. Furthermore, in mildly and moderately affected patients, compliance is sometimes limited due to various side effects. A valuable alternative, which has been suggested for these patients, is the so-called positional therapy. The aim of the therapy is to make the supine position uncomfortable so that patients actively avoid it. However, due to interruption of the sleep because of acoustic signals or an obstacle fixes at the patients back, current treatment options are associated with low long term compliance.
Mechanisms for turning a sleeping user sideward
In literature, several mechanisms have been proposed to shift the sleeping user of a bed form supine to lateral position. In general, these methods can be sorted into the following four categories:
- Inclination of one side of the mattress
- Tilting of the mattress around a middle axis
- Using pressurized air chambers to reconfigure the mattress shape
- Using vibration or disturbing stimuli as aversion therapy when the person is sleeping on the back Method number 4 does require active participation of the user and would therefore have the same limitations as conventional positional therapy. However, method 1 to 3 are promising candidates for an intelligent anti-sleep apnea bed.
Methods
In order to compare the three methods described above a custom-made automated bed that has a pressurized air-mattress and provides the ability either to incline half of the bed surface up to 70° or tilt the whole surface up to 45° was developed. The purpose of this study is to evaluate which of these three mechanisms is more effective in changing the position of the user from supine to lateral. Furthermore, the settings which are most likely to induce a position change will be determined. In addition, it will be evaluated which test settings cause the least arousals in sleeping users. Evaluating this in healthy participants is an important step on our way towards an intelligent bed for treatment of position dependent obstructive sleep apnea.
- Conditions
- Sleep Apnea
- Being tested
- Sidewards Tilting Bed
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sidewards Tilting BedDevice
Sidewards tilting of the bed is hypothesized to induce a body position change in sleeping subjects.
| Study group | Role | What they receive |
|---|---|---|
| Sideward Tilt of Bed | Experimental | During sleep, while lying in supine position, the participant will be tilted sidewards by the bed. In practice, the experimenter activates the bed at timepoints during the night where the participant is lying in supine position. Activating the bed results in one half of the bed lifting 10 to 40 Degrees sidewards. Receives: Device: Sidewards Tilting Bed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in position of the upper body
Change in the position of the upper body in degree of turning around the longitudinal axis (derived from infrared Video and from bodyworn position sensor)
Measured: 1 year
Arousals from sleep
Change of the orientation of the upper body assessed with the polysomnography device (asleep)
Measured: 1 year
Secondary outcomes (1)
Performance of the sensors
Accuracy, Sensitivity, Specificity of the pressure sensors in the matress
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start10 Mar 2020
- Primary completion19 Jul 2020
- Study completion19 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep ApneaStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Riener, Prof. Dr., Principal investigator, Swiss Federal Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265118
- Sponsor's protocol ID
- SideBed
- Status last verified
- Jul 2020
- First submitted
- 30 Jan 2020
- Last updated
- 3 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We consider uploading the polysomnography data (electroencephalography, electromyography, electrooculography) of the night time measurements to the ETH Research Collection database to make them available to other investigators.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Sideward Turning Beds to Treat Positional Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT04265118
- Acronym / sponsor ID
- SideBed
- Conditions
- Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 10 Mar 2020 (actual)
- Primary completion
- 19 Jul 2020 (actual)
- Study completion
- 19 Jul 2020 (actual)
- First posted
- 11 Feb 2020 (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 feasibility study is to compare different settings of a custom-made automated bed with respect to their ability to induce a change in the sleeping position of the user. In particular, it is of interest whether the bed mechanism is able to change the position of a user from supine to lateral position. At the same time, the investigators want to know whether the intervention provided by the bed results in an arousal in sleeping users. In addition, feasibility of detecting the position of the user using the un-obtrusive pressure sensors, which are integrated in the bed, will be assessed.
Within the experiment, the investigators will identify participants that are sleeping mainly in supine position by doing an acti-watch based screening measurement in their home setting. Those participants who are sleeping in supine position for more than 12.5% of the home recording with the acti-watch will be invited to come to the lab for one night measurement. The experimenter will trigger interventions of the bed manually when the participant is lying in supine position. The investigators will evaluate the position change using infrared cameras and the built in sensors of the bed. Furthermore, a commercially available home-measurement device to record polysomnography will be used to evaluate whether the intervention caused arousals.
Detailed description
Obstructive positional sleep apnea
Obstructive sleep apnea (OSA) is characterised by a repetitive collapse of the upper airway during sleep, which results in apnea or hypopnoea associated with oxygen desaturations and arousals. OSA affects up to 30% of the adult male population, increases with age, and is associated with daytime sleepiness, increased risk of traffic accidents, arterial hypertension, vascular dysfunction and cardiovascular events. In 56% to 75% percent of these apnea patients, the apnea-hypopnea index is correlating with the body position. This subgroup of patients suffers from position-dependent sleep apnea, which is defined by a difference in the apnea hypopnea index between supine position and non-supine positions of at least 50%. Current treatment recommendation for OSA is continuous positive airway pressure (CPAP) ventilation, because of its potential beneficial impact on cardiovascular outcomes. However, a recent randomised controlled trial has not shown reduction in major cardiovascular endpoints in OSA patients with manifest cardiovascular disease allocated to CPAP. Therefore, the beneficial effect of CPAP treatment has been subject to extensive discussion recently. Furthermore, in mildly and moderately affected patients, compliance is sometimes limited due to various side effects. A valuable alternative, which has been suggested for these patients, is the so-called positional therapy. The aim of the therapy is to make the supine position uncomfortable so that patients actively avoid it. However, due to interruption of the sleep because of acoustic signals or an obstacle fixes at the patients back, current treatment options are associated with low long term compliance.
Mechanisms for turning a sleeping user sideward
In literature, several mechanisms have been proposed to shift the sleeping user of a bed form supine to lateral position. In general, these methods can be sorted into the following four categories:
- Inclination of one side of the mattress
- Tilting of the mattress around a middle axis
- Using pressurized air chambers to reconfigure the mattress shape
- Using vibration or disturbing stimuli as aversion therapy when the person is sleeping on the back Method number 4 does require active participation of the user and would therefore have the same limitations as conventional positional therapy. However, method 1 to 3 are promising candidates for an intelligent anti-sleep apnea bed.
Methods
In order to compare the three methods described above a custom-made automated bed that has a pressurized air-mattress and provides the ability either to incline half of the bed surface up to 70° or tilt the whole surface up to 45° was developed. The purpose of this study is to evaluate which of these three mechanisms is more effective in changing the position of the user from supine to lateral. Furthermore, the settings which are most likely to induce a position change will be determined. In addition, it will be evaluated which test settings cause the least arousals in sleeping users. Evaluating this in healthy participants is an important step on our way towards an intelligent bed for treatment of position dependent obstructive sleep apnea.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sideward Tilt of Bed | Experimental | Device: Sidewards Tilting BedDuring sleep, while lying in supine position, the participant will be tilted sidewards by the bed. In practice, the experimenter activates the bed at timepoints during the night where the participant is lying in supine position. Activating the bed results in one half of the bed lifting 10 to 40 Degrees sidewards. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 12.5 % of the sleep in the screening night spent in supine position.
Key exclusion criteria (5 listed)
- Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
- Injuries or pain that prevents sleeping in supine or lateral position.
- Pregnancy.
- Length longer than 2 m (larger than standard bed).
- investigators, their family members, employees and other dependent persons^.
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 |
|---|---|---|
| Sidewards Tilting BedSidewards tilting of the bed is hypothesized to induce a body position change in sleeping subjects. | Device | Sideward Tilt of Bed |
Primary outcome
Change in position of the upper body
Time frame: 1 year
Change in the position of the upper body in degree of turning around the longitudinal axis (derived from infrared Video and from bodyworn position sensor)
Arousals from sleep
Time frame: 1 year
Change of the orientation of the upper body assessed with the polysomnography device (asleep)
1 secondary outcome
Performance of the sensors
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2020.
- Individual participant dataSharing planned: Yes. We consider uploading the polysomnography data (electroencephalography, electromyography, electrooculography) of the night time measurements to the ETH Research Collection database to make them available to other investigators.
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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.
Robert Riener, Prof. Dr. principal investigator
Swiss Federal Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sidewards Tilting Bed in people with Sleep Apnea, 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 3 Aug 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in position of the upper body (time frame: 1 year). The study lists 2 primary outcomes in all. 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 3 Aug 2020.