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Effect of Device Guided Breathing on Sleeplessness (2BRT01) (2BRT01)

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ClinicalTrials.gov Identifier: NCT02521324
Recruitment Status : Not yet recruiting
First Posted : August 13, 2015
Last Update Posted : January 9, 2018
Sponsor:
Collaborator:
Sheba Medical Center
Information provided by (Responsible Party):
Afeka, The Tel-Aviv Academic College of Engineering

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Sleep Initiation and Maintenance Disorders Device: DGB2 Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Device-Guided Breathing on Healthy Subjects With Sleeplessness Using a Sensor and Mobile App
Estimated Study Start Date : May 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: Immediate treatment (IT)
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.
Device: DGB2
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 .
Other Name: Device Guided Breathing
Active Comparator: Wait list control (WLC)
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.
Device: DGB2
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 .
Other Name: Device Guided Breathing



Primary Outcome Measures :
  1. Change in Energetic/Fatigue visual analogue scale (VAS) from baseline to completion of 2 weeks of DGB [ Time Frame: 2 weeks ]

Secondary Outcome Measures :
  1. Changes in sleep onset latency (SOL) from baseline to completion of 2 weeks of DGB [ Time Frame: 2 weeks ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy with mild to moderate sleeplessness
  2. Male or Female, Age 18-65
  3. Has ipod/ipad or smartphone compatible with the system used in the study
  4. Has access to internet and email
  5. Knowledge of English to the level of understanding the App and the sleep-monitor interface.

Exclusion Criteria:

  1. Known sleep or respiration disorder
  2. A serious systemic disease
  3. Pittsburg Insomnia Rating Scale (PIRS_2) <2
  4. Pregnant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02521324


Contacts
Contact: Vital Biton +972-50-454-1515 2SleepGood@gmail.com

Locations
Israel
Afeka, Tel-Aviv Academic College of Engineering Not yet recruiting
Tel-aviv, Please Select Region, State Or Province, Israel, 65220
Contact: Vital Biton    +972-50-454-1515    2SleepGood@gmail.com   
Sponsors and Collaborators
Afeka, The Tel-Aviv Academic College of Engineering
Sheba Medical Center
Investigators
Principal Investigator: Moshe Halak, MD Sheba Medical Center
Study Director: Zehava Blechman, PhD Afeka, Tel-Aviv Academic College of Engineering/

Responsible Party: Afeka, The Tel-Aviv Academic College of Engineering
ClinicalTrials.gov Identifier: NCT02521324     History of Changes
Other Study ID Numbers: 2361-15-SMC
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders