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Effect of Device Guided Breathing on Sleeplessness (2BRT01)

NCT02521324 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-11-16

No results posted yet for this study

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.

Conditions

  • Sleep Initiation and Maintenance Disorders

Interventions

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 .

Sponsors & Collaborators

  • Sheba Medical Center

    collaborator OTHER_GOV

  • Afeka, The Tel-Aviv Academic College of Engineering

    lead OTHER

Principal Investigators

  • Moshe Halak, MD · Sheba Medical Center

  • Zehava Blechman, PhD · Afeka, Tel-Aviv Academic College of Engineering/

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-31
Primary Completion
2019-12-31
Completion
2020-01-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02521324 on ClinicalTrials.gov