Jet Lag DisorderNCT02560103
An Observational Study to Investigate the Effects of Rapid Transmeridian Travel
An observational study of Jet Lag Disorder, run by Vanda Pharmaceuticals at 2 sites in United States.
Trial summary
Observational study to investigate circadian rhythm patterns Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Jet Lag Disorder
- What is being tested?
- Transmeridian travel across multiple time zones
- How many people
- 119 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2015to Oct 2017
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Ability and acceptance to provide written consent
- Men or women between 18-75 years
- Body Mass Index of ≥ 18 and ≤ 30 kg/m2
Who cannot join
- History (within the 12 months prior to screening) of psychiatric disorders
- Major surgery, trauma, illness or immobile for 3 or more days within the past month
- Pregnancy or recent pregnancy (within 6 weeks)
- A positive test for drugs of abuse at the screening visit
- Any other sound medical reason as determined by the clinical investigator
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, 20815
Santa Monica Clinical Trials
Santa Monica, California, 90404
About this study
Official title: An Observational Study to Investigate the Effects of Rapid Travel
Observational study to investigate circadian rhythm patterns
- Conditions
- Jet Lag Disorder
- Being tested
- Transmeridian travel across multiple time zones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transmeridian travel across multiple time zonesOther
| Study group | Role | What they receive |
|---|---|---|
| Single group | No treatment Receives: Other: Transmeridian travel across multiple time zones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of transmeridian travel on nighttime sleep after transmeridian travel measured by Polysomnography (PSG)
Measured: 4 days
Karolinska Sleepiness Scale (KSS) in subjects who experienced rapid transmeridian travel.
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jet Lag DisorderStudies of the same condition, open and under way.
- More trials run by Vanda PharmaceuticalsThe sponsor's other registered studies.
- 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanda Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02560103
- Sponsor's protocol ID
- VP-VEC-162-0101
- Status last verified
- Jun 2018
- First submitted
- 21 Sep 2015
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Investigate the Effects of Rapid Travel
- ClinicalTrials.gov ID
- NCT02560103
- Acronym / sponsor ID
- VP-VEC-162-0101
- Conditions
- Jet Lag Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Vanda PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 25 Sep 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.
Observational study to investigate circadian rhythm patterns
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | – | Other: Transmeridian travel across multiple time zonesNo treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Ability and acceptance to provide written consent
- Men or women between 18-75 years
- Body Mass Index of ≥ 18 and ≤ 30 kg/m2
Key exclusion criteria (5 listed)
- History (within the 12 months prior to screening) of psychiatric disorders
- Major surgery, trauma, illness or immobile for 3 or more days within the past month
- Pregnancy or recent pregnancy (within 6 weeks)
- A positive test for drugs of abuse at the screening visit
- Any other sound medical reason as determined by the clinical investigator
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 |
|---|---|---|
| Transmeridian travel across multiple time zones | Other | Single group |
Primary outcome
Effects of transmeridian travel on nighttime sleep after transmeridian travel measured by Polysomnography (PSG)
Time frame: 4 days
Karolinska Sleepiness Scale (KSS) in subjects who experienced rapid transmeridian travel.
Time frame: 4 days
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 26 Jun 2018.
Related trials for Jet Lag Disorder
Recruiting
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Not yet recruiting
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Obstructive Sleep Apnea
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Jet Lag Disorder, run by Vanda Pharmaceuticals at 2 sites in United States.
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 3 inclusion and 5 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 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Effects of transmeridian travel on nighttime sleep after transmeridian travel measured by Polysomnography (PSG) (time frame: 4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jun 2018.