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An Observational Study to Investigate the Effects of Rapid Transmeridian Travel

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02560103
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : June 26, 2018
Sponsor:
Information provided by (Responsible Party):
Vanda Pharmaceuticals

Tracking Information
First Submitted Date September 21, 2015
First Posted Date September 25, 2015
Last Update Posted Date June 26, 2018
Study Start Date September 2015
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 8, 2016)
  • 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 ]
Original Primary Outcome Measures
 (submitted: September 23, 2015)
  • Effects of transmeridian travel on nighttime sleep after transmeridian travel measured by Polysomnography (PSG) [ Time Frame: 4 days ]
  • Effects of transmeridian travel on excessive daytime sleepiness measured by Maintenance of Wakefulness Test (MWT_ [ Time Frame: one day ]
  • Karolinska Sleepiness Scale (KSS) in subjects who experienced rapid transmeridian travel. [ Time Frame: 4 days ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study to Investigate the Effects of Rapid Transmeridian Travel
Official Title An Observational Study to Investigate the Effects of Rapid Travel
Brief Summary Observational study to investigate circadian rhythm patterns
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy volunteers
Condition Jet Lag Disorder
Intervention Other: Transmeridian travel across multiple time zones
Study Groups/Cohorts Single group
No treatment
Intervention: Other: Transmeridian travel across multiple time zones
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 22, 2018)
119
Original Estimated Enrollment
 (submitted: September 23, 2015)
25
Actual Study Completion Date October 2017
Actual Primary Completion Date October 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Ability and acceptance to provide written consent
  • Men or women between 18-75 years
  • Body Mass Index of ≥ 18 and ≤ 30 kg/m2

Exclusion Criteria:

  • 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02560103
Other Study ID Numbers VP-VEC-162-0101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Vanda Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor Vanda Pharmaceuticals
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account Vanda Pharmaceuticals
Verification Date June 2018