Travel, Sleep Related DisorderNCT02636478
Travelling in Patients With Sleep Related Breathing Disorders
An observational study of Travel, Sleep Related Disorder, run by Wissenschaftliches Institut Bethanien e.V.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Travel, Sleep Related Disorder
- What is being tested?
- questionnaire for travel habits
- How many people
- 345 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to Apr 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with sleep related breathing disorder
Who may be able to join
- patients with sleep related breathing disorder
- informed consent provided
Who cannot join
- patients with no sleep related breathing disorder
- no informed consent provided
About this study
Official title: 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.
Read the 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.
- Conditions
- Travel, Sleep Related Disorder
- Being tested
- questionnaire for travel habits
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire for travel habitsOther
questionnaire has been used to collect information about travelling
| Study group | Role | What they receive |
|---|---|---|
| reference group | therapy naive patients with a sleep related breathing disorder Receives: Other: questionnaire for travel habits | |
| therapy group | patients with devices treating their sleep related breathing disorder Receives: Other: questionnaire for travel habits |
What is being measured
The primary outcome is the main question the study is designed to answer.
travel activities in sleep related breathing disorder, questionnaire
questionnaire has been used once in each patient
Measured: ten minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2015 (estimated)
- Study startApr 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Travel, Sleep Related DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.V
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02636478
- Sponsor's protocol ID
- WI_23/2013
- Status last verified
- Dec 2015
- First submitted
- 2 Nov 2015
- Last updated
- 21 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 24286897Sinagawa 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.
PubMed 24697351
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Travel Activities in Patients With Sleep Related Breathing Disorders
- ClinicalTrials.gov ID
- NCT02636478
- Acronym / sponsor ID
- WI_23/2013
- Conditions
- Travel, Sleep Related Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- Wissenschaftliches Institut Bethanien e.VUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 21 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| reference group | – | Other: questionnaire for travel habitstherapy naive patients with a sleep related breathing disorder |
| therapy group | – | Other: questionnaire for travel habitspatients with devices treating their sleep related breathing disorder |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with sleep related breathing disorder
Key inclusion criteria (2 listed)
- patients with sleep related breathing disorder
- informed consent provided
Key exclusion criteria (2 listed)
- patients with no sleep related breathing disorder
- no informed consent provided
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| questionnaire for travel habitsquestionnaire has been used to collect information about travelling | Other | reference group, therapy group |
Primary outcome
travel activities in sleep related breathing disorder, questionnaire
Time frame: ten minutes
questionnaire has been used once in each patient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2015.
- Background: PubMed 24286897Quera 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.
- Background: PubMed 24697351Sinagawa 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Travel, Sleep Related Disorder, run by Wissenschaftliches Institut Bethanien e.V.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
travel activities in sleep related breathing disorder, questionnaire (time frame: ten minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02636478, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2015.