- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02636478
Travelling in Patients With Sleep Related Breathing Disorders
December 18, 2015 updated by: Wissenschaftliches Institut Bethanien e.V
Travel Activities in Patients With Sleep Related Breathing Disorders
One questionnaire has been configured to ask therapy naive and treated patients about their travel activities.
Travel activities include private and professional traveling.
Another questionnaire collects medical information.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Including a German sleep committee a new questionnaire has been created to ask patients about their travel Habits.
Only travels over a onenightstay were of interest.
All detailed Information about the Destination has been asked.
A Special Point of interest were the Impacts of traveling.
For each Patient a doctor completed the medical history including sleep related breathing disorder and relevant medical conditions e.g.
orthopedic Impacts.
Study Type
Observational
Enrollment (Actual)
345
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with sleep related breathing disorder
Description
Inclusion Criteria:
- patients with sleep related breathing disorder
- informed consent provided
Exclusion Criteria:
- patients with no sleep related breathing disorder
- no informed consent provided
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
reference group
therapy naive patients with a sleep related breathing disorder
|
questionnaire has been used to collect information about travelling
|
|
therapy group
patients with devices treating their sleep related breathing disorder
|
questionnaire has been used to collect information about travelling
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
travel activities in sleep related breathing disorder, questionnaire
Time Frame: ten minutes
|
questionnaire has been used once in each patient
|
ten minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Quera Salva MA, Barbot F, Hartley S, Sauvagnac R, Vaugier I, Lofaso F, Philip P. Sleep disorders, sleepiness, and near-miss accidents among long-distance highway drivers in the summertime. Sleep Med. 2014 Jan;15(1):23-6. doi: 10.1016/j.sleep.2013.06.018. Epub 2013 Sep 14.
- Sinagawa DM, De Carvalho HB, Andreuccetti G, Do Prado NV, De Oliveira KC, Yonamine M, Munoz DR, Gjerde H, Leyton V. Association between travel length and drug use among Brazilian truck drivers. Traffic Inj Prev. 2015;16(1):5-9. doi: 10.1080/15389588.2014.906589. Epub 2014 Sep 26.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (ACTUAL)
April 1, 2014
Study Completion (ACTUAL)
April 1, 2014
Study Registration Dates
First Submitted
November 2, 2015
First Submitted That Met QC Criteria
December 18, 2015
First Posted (ESTIMATE)
December 21, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
December 21, 2015
Last Update Submitted That Met QC Criteria
December 18, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WI_23/2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.