Sleep Initiation and Maintenance Disorders2BRT01NCT02521324
Effect of Device Guided Breathing on Sleeplessness (2BRT01)
A study testing DGB2 in people with Sleep Initiation and Maintenance Disorders, run by Afeka, The Tel-Aviv Academic College of Engineering at 1 site in Israel.
Trial summary
The current study is designed to evaluate the effect of device guided breathing (DGB) on sleeplessness. Healthy subjects with mild to moderate sleeplessness that wish to improve their sleep quality will be included in this study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- DGB2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- May 2018to Jan 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy with mild to moderate sleeplessness
- Male or Female, Age 18-65
- Has ipod/ipad or smartphone compatible with the system used in the study
- Has access to internet and email
- Knowledge of English to the level of understanding the App and the sleep-monitor interface.
Who cannot join
- Known sleep or respiration disorder
- A serious systemic disease
- Pittsburg Insomnia Rating Scale (PIRS_2) <2
- Pregnant
Trial locations and contacts
1 site in 1 country.
Israel1 site
Afeka, Tel-Aviv Academic College of Engineering
Tel Aviv, Please Select Region, State Or Province, 65220
About this study
Official title: The Effect of Device-Guided Breathing on Healthy Subjects With Sleeplessness Using a Sensor and Mobile App
The current study is designed to evaluate the effect of device guided breathing (DGB) on sleeplessness. Healthy subjects with mild to moderate sleeplessness that wish to improve their sleep quality will be included in this study. The subjects will receive a belt type breathing sensor, download the app on their smartphone, and will be required to perform DGB at their home setting for 2 weeks after a baseline period.
Read the detailed description
Sleeplessness, defined as difficulty in falling asleep or maintaining sleep, is prevalent in about one third of the US population. Sleeplessness was found to have negative impact on the quality of life and daily functionality and in its chronic form, was also found to frequently lead to sympathetic over-activity. Stress is an important factor in triggering and exacerbating sleeplessness and its symptoms.
Current methods for alleviating the problem include drugs, modification of sleep habits (also delivered via smartphones), cognitive behavior therapy that includes relaxation techniques such as mindfulness, meditation, and diaphragmatic breathing.
Breathing pattern modification, as done by Device Guided Breathing (DGB) was found to affect beneficially the cardiovascular system. DGB guides its user in reducing breathing rate gradually from normal values (12-20 breaths/min) to slow rates (4-6 breaths/min) while increasing the relative duration of the exhalation phase. This is done by composing in real time musical tones from monitored respiration data with which the user synchronizes breathing
Breathing pattern modification, as done by DGB was originally implemented in a device called RESPeRATE that was cleared by the FDA for treating hypertension and stress and its use was supported by multiple clinical trials. However, the direct effect of DGB on sleeplessness has not yet been investigated,
DGB was recently implemented in a mobile system that consists of a Bluetooth enabled belt-type breathing sensor and an iOS mobile application ('App'). The App accumulates continuously breathing-related data and performance measure. The accumulated data are sent to an icloud-based server.
The current study is a single center, prospective, randomized, waiting-list-controlled (WLC) clinical trial designed to evaluate the effect of DGB on sleeplessness using the mobile DGB2 system.
- Being tested
- DGB2
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DGB2Device
Also called Device Guided Breathing
DGB guides its user in reducing breathing rate gradually from normal values (12-20 breaths/min) to slow rates (4-6 breaths/min) while increasing the relative duration of the exhalation phase. This is done by composing in real time musical tones from monitored respiration data with which the user synchronizes breathing .
| Study group | Role | What they receive |
|---|---|---|
| Immediate treatment (IT) | Experimental | Subjects from this group will perform 2 weeks of DGB with the DGB2 system immediately after 1 week of baseline monitoring. All subjects will answer questionnaires pertaining to their sleep quality. Receives: Device: DGB2 |
| Wait list control (WLC) | Active comparator | The subjects from the WLC group will do the same (answer questionnaires and perform 2 weeks of DGB with the DGB2 system) at a 1 week delay. Receives: Device: DGB2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Energetic/Fatigue visual analogue scale (VAS) from baseline to completion of 2 weeks of DGB
Measured: 2 weeks
Secondary outcomes (1)
Changes in sleep onset latency (SOL) from baseline to completion of 2 weeks of DGB
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startMay 2018 (estimated)
- Primary completionDec 2019 (estimated)
- Study completionJan 2020 (estimated)
Why it stopped: Decided to redesign the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Initiation and Maintenance DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Afeka, The Tel-Aviv Academic College of Engineering
- Sponsor type
- University, hospital or other
- Collaborators
- Sheba Medical Center
- Responsible party
- Sponsor
- Investigators
- Moshe Halak, MD, Principal investigator, Sheba Medical CenterZehava Blechman, PhD, Study director, Afeka, Tel-Aviv Academic College of Engineering/
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02521324
- Sponsor's protocol ID
- 2361-15-SMC
- Acronym
- 2BRT01
- Status last verified
- Nov 2021
- First submitted
- 10 Aug 2015
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Device-Guided Breathing on Healthy Subjects With Sleeplessness Using a Sensor and Mobile App
- ClinicalTrials.gov ID
- NCT02521324
- Acronym / sponsor ID
- 2BRT01 / 2361-15-SMC
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decided to redesign the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Afeka, The Tel-Aviv Academic College of EngineeringUniversity, hospital or other
- Collaborators
- Sheba Medical Center
- Study start
- May 2018 (estimated)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 13 Aug 2015 (estimated)
- 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 current study is designed to evaluate the effect of device guided breathing (DGB) on sleeplessness. Healthy subjects with mild to moderate sleeplessness that wish to improve their sleep quality will be included in this study. The subjects will receive a belt type breathing sensor, download the app on their smartphone, and will be required to perform DGB at their home setting for 2 weeks after a baseline period.
Detailed description
Sleeplessness, defined as difficulty in falling asleep or maintaining sleep, is prevalent in about one third of the US population. Sleeplessness was found to have negative impact on the quality of life and daily functionality and in its chronic form, was also found to frequently lead to sympathetic over-activity. Stress is an important factor in triggering and exacerbating sleeplessness and its symptoms.
Current methods for alleviating the problem include drugs, modification of sleep habits (also delivered via smartphones), cognitive behavior therapy that includes relaxation techniques such as mindfulness, meditation, and diaphragmatic breathing.
Breathing pattern modification, as done by Device Guided Breathing (DGB) was found to affect beneficially the cardiovascular system. DGB guides its user in reducing breathing rate gradually from normal values (12-20 breaths/min) to slow rates (4-6 breaths/min) while increasing the relative duration of the exhalation phase. This is done by composing in real time musical tones from monitored respiration data with which the user synchronizes breathing
Breathing pattern modification, as done by DGB was originally implemented in a device called RESPeRATE that was cleared by the FDA for treating hypertension and stress and its use was supported by multiple clinical trials. However, the direct effect of DGB on sleeplessness has not yet been investigated,
DGB was recently implemented in a mobile system that consists of a Bluetooth enabled belt-type breathing sensor and an iOS mobile application ('App'). The App accumulates continuously breathing-related data and performance measure. The accumulated data are sent to an icloud-based server.
The current study is a single center, prospective, randomized, waiting-list-controlled (WLC) clinical trial designed to evaluate the effect of DGB on sleeplessness using the mobile DGB2 system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate treatment (IT) | Experimental | Device: DGB2Subjects from this group will perform 2 weeks of DGB with the DGB2 system immediately after 1 week of baseline monitoring. All subjects will answer questionnaires pertaining to their sleep quality. |
| Wait list control (WLC) | Active comparator | Device: DGB2The subjects from the WLC group will do the same (answer questionnaires and perform 2 weeks of DGB with the DGB2 system) at a 1 week delay. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy with mild to moderate sleeplessness
- Male or Female, Age 18-65
- Has ipod/ipad or smartphone compatible with the system used in the study
- Has access to internet and email
- Knowledge of English to the level of understanding the App and the sleep-monitor interface.
Key exclusion criteria (4 listed)
- Known sleep or respiration disorder
- A serious systemic disease
- Pittsburg Insomnia Rating Scale (PIRS_2) <2
- Pregnant
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 |
|---|---|---|
| DGB2Also: Device Guided BreathingDGB guides its user in reducing breathing rate gradually from normal values (12-20 breaths/min) to slow rates (4-6 breaths/min) while increasing the relative duration of the exhalation phase. This is done by composing in real time musical tones from monitored respiration data with which the user synchronizes breathing . | Device | Immediate treatment (IT), Wait list control (WLC) |
Primary outcome
Change in Energetic/Fatigue visual analogue scale (VAS) from baseline to completion of 2 weeks of DGB
Time frame: 2 weeks
1 secondary outcome
Changes in sleep onset latency (SOL) from baseline to completion of 2 weeks of DGB
Time frame: 2 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
Moshe Halak, MD principal investigator
Sheba Medical Center
Zehava Blechman, PhD study director
Afeka, Tel-Aviv Academic College of Engineering/
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DGB2 in people with Sleep Initiation and Maintenance Disorders, run by Afeka, The Tel-Aviv Academic College of Engineering at 1 site in Israel.
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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 16 Nov 2021. 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 Israel. 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 withdrawn before enrolling participants, so there are no results.
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 Energetic/Fatigue visual analogue scale (VAS) from baseline to completion of 2 weeks of DGB (time frame: 2 weeks). 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 16 Nov 2021.