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

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.

Study Overview

• Status: Withdrawn
• Conditions: Sleep Initiation and Maintenance Disorders
• Intervention / Treatment: Device: DGB2

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
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Please Select Region, State Or Province
    • Tel-aviv, Please Select Region, State Or Province, Israel, 65220
      • Afeka, Tel-Aviv Academic College of Engineering

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Device Guided Breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Energetic/Fatigue visual analogue scale (VAS) from baseline to completion of 2 weeks of DGB	2 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes in sleep onset latency (SOL) from baseline to completion of 2 weeks of DGB	2 weeks

Collaborators and Investigators

• Sponsor: Afeka, The Tel-Aviv Academic College of Engineering
• Collaborators: Sheba Medical Center
• Investigators: Principal Investigator: Moshe Halak, MD, Sheba Medical Center; Study Director: Zehava Blechman, PhD, Afeka, Tel-Aviv Academic College of Engineering/

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2018
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: August 10, 2015
• First Submitted That Met QC Criteria: August 12, 2015
• First Posted (Estimate): August 13, 2015

Study Record Updates

• Last Update Posted (Actual): November 16, 2021
• Last Update Submitted That Met QC Criteria: November 8, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: 2361-15-SMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No