STeP IT UP CF: STimulating ImProved Health And Well-being In CysTic Fibrosis
NCT ID: NCT04018495
Last Updated: 2025-02-03
Study Results
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View full resultsBasic Information
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COMPLETED
21 participants
OBSERVATIONAL
2019-09-10
2022-08-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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CF patients using Fitbit for 3 months
CF patients at time of enrollment who are willing to use a fitbit tracker to measure activity and sleep during the observational period of 3 months.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Age \>18, Cystic Fibrosis
Exclusion Criteria
* Those patients without dedicated access to a smartphone, tablet, or computer with internet for syncing device and completing patient diary.
* Those patients unwilling to sign an informed consent form.
18 Years
100 Years
ALL
No
Sponsors
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Cystic Fibrosis Foundation
OTHER
Medical College of Wisconsin
OTHER
Responsible Party
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Rose Franco
Associate Professor
Principal Investigators
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Rose Franco, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States
Countries
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References
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Amin R, Bean J, Burklow K, Jeffries J. The relationship between sleep disturbance and pulmonary function in stable pediatric cystic fibrosis patients. Chest. 2005 Sep;128(3):1357-63. doi: 10.1378/chest.128.3.1357.
Beattie Z, Oyang Y, Statan A, Ghoreyshi A, Pantelopoulos A, Russell A, Heneghan C. Estimation of sleep stages in a healthy adult population from optical plethysmography and accelerometer signals. Physiol Meas. 2017 Oct 31;38(11):1968-1979. doi: 10.1088/1361-6579/aa9047.
Dancey DR, Tullis ED, Heslegrave R, Thornley K, Hanly PJ. Sleep quality and daytime function in adults with cystic fibrosis and severe lung disease. Eur Respir J. 2002 Mar;19(3):504-10. doi: 10.1183/09031936.02.00088702.
de Zambotti M, Baker FC, Colrain IM. Validation of Sleep-Tracking Technology Compared with Polysomnography in Adolescents. Sleep. 2015 Sep 1;38(9):1461-8. doi: 10.5665/sleep.4990.
Gonzalez-Ortiz M, Martinez-Abundis E, Balcazar-Munoz BR, Pascoe-Gonzalez S. Effect of sleep deprivation on insulin sensitivity and cortisol concentration in healthy subjects. Diabetes Nutr Metab. 2000 Apr;13(2):80-3.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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Sample size requirements for estimating Pearson, Kendall and Spearman Correlations. Insufficient sleep is a public health problem. Cystic Fibrosis Trust Cystic Fibrosis Registry Report
Other Identifiers
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34812
Identifier Type: -
Identifier Source: org_study_id
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