Effect of Device Guided Breathing on Sleeplessness (2BRT01)

Sleep Initiation and Maintenance Disorders Clinical Trial

— 2BRT01  

Official title:

The Effect of Device-Guided Breathing on Healthy Subjects With Sleeplessness Using a Sensor and Mobile App

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02521324
• Other study ID #: 2361-15-SMC
• Status: Withdrawn
• Phase: N/A
• Start date: May 2018
• Est. completion date: January 2020

Study information

• Verified date: November 2021
• Source: Afeka, The Tel-Aviv Academic College of Engineering
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Initiation and Maintenance Disorders

Intervention

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 .

Locations

Country	Name	City	State
Israel	Afeka, Tel-Aviv Academic College of Engineering	Tel-aviv	Please Select Region, State Or Province

Sponsors (2)

Lead Sponsor	Collaborator
Afeka, The Tel-Aviv Academic College of Engineering	Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Energetic/Fatigue visual analogue scale (VAS) from baseline to completion of 2 weeks of DGB		2 weeks
Secondary	Changes in sleep onset latency (SOL) from baseline to completion of 2 weeks of DGB		2 weeks