Clinical trial NCT02521324: Effect of Device Guided Breathing on Sleeplessness (2BRT01)
Official title: The Effect of Device-Guided Breathing on Healthy Subjects With Sleeplessness Using a Sensor and Mobile App
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sleep Initiation and Maintenance Disorders
Lead sponsor: Afeka, The Tel-Aviv Academic College of Engineering
Sponsor class: OTHER
Collaborators: name: Sheba Medical Center
First posted: 2015-08-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Energetic/Fatigue visual analogue scale (VAS) from baseline to completion of 2 weeks of DGB
timeFrame: 2 weeks
Secondary outcomes:
measure: Changes in sleep onset latency (SOL) from baseline to completion of 2 weeks of DGB
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Tel-aviv
country: Israel
facility: Afeka, Tel-Aviv Academic College of Engineering
state: Please Select Region, State Or Province
Study officials:
affiliation: Sheba Medical Center
name: Moshe Halak, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Afeka, Tel-Aviv Academic College of Engineering/
name: Zehava Blechman, PhD
role: STUDY_DIRECTOR
References: