Effect of Device Guided Breathing on Sleeplessness (2BRT01)

NCT02521324 | Withdrawn

• 1 other identifier: 2361-15-SMC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Initiation and Maintenance Disorders

Outcome Measures

Primary Outcomes (1)

• Change in Energetic/Fatigue visual analogue scale (VAS) from baseline to completion of 2 weeks of DGB

  2 weeks

Secondary Outcomes (1)

• Changes in sleep onset latency (SOL) from baseline to completion of 2 weeks of DGB

  2 weeks

Study Arms (2)

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.

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.

Device: DGB2

Interventions

DGB2 DEVICE

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 .

Also known as: Device Guided Breathing

Immediate treatment (IT); Wait list control (WLC)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Known sleep or respiration disorder
• A serious systemic disease
• Pittsburg Insomnia Rating Scale (PIRS\_2) \<2
• Pregnant

Sponsors & Collaborators

• Afeka, The Tel-Aviv Academic College of Engineering: lead
• Sheba Medical Center: collaborator

Study Sites (1)

Afeka, Tel-Aviv Academic College of Engineering

Tel Aviv, Please Select Region, State Or Province, 65220, Israel

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Moshe Halak, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

• Zehava Blechman, PhD

  Afeka, Tel-Aviv Academic College of Engineering/

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2015
• First Posted: August 13, 2015
• Study Start: May 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: January 1, 2020
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

IL (1)