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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 November 2021 |
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Main ID: |
NCT02521324 |
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Date of registration:
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10/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Effect of Device Guided Breathing on Sleeplessness (2BRT01)
2BRT01 |
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Scientific title:
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The Effect of Device-Guided Breathing on Healthy Subjects With Sleeplessness Using a Sensor and Mobile App |
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Date of first enrolment:
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May 2018 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT02521324 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Zehava Blechman, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Afeka, Tel-Aviv Academic College of Engineering/ |
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Name:
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Moshe Halak, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Sheba Medical Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sleep Initiation and Maintenance Disorders
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Intervention(s)
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Device: DGB2
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Primary Outcome(s)
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Change in Energetic/Fatigue visual analogue scale (VAS) from baseline to completion of 2 weeks of DGB
[Time Frame: 2 weeks]
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Secondary Outcome(s)
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Changes in sleep onset latency (SOL) from baseline to completion of 2 weeks of DGB
[Time Frame: 2 weeks]
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Secondary ID(s)
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2361-15-SMC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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