An Observational Study to Investigate the Effects of Rapid Transmeridian Travel

June 22, 2018 updated by: Vanda Pharmaceuticals

An Observational Study to Investigate the Effects of Rapid Travel

Observational study to investigate circadian rhythm patterns

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

119

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Santa Monica Clinical Trials
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • The Center for Sleep & Wake Disorders

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 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers

Description

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

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
Single group
No treatment
Other: Transmeridian travel across multiple time zones

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effects of transmeridian travel on nighttime sleep after transmeridian travel measured by Polysomnography (PSG)
Time Frame: 4 days
4 days
Karolinska Sleepiness Scale (KSS) in subjects who experienced rapid transmeridian travel.
Time Frame: 4 days
4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanda Pharmaceuticals

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

September 1, 2015

Primary Completion (ACTUAL)

October 1, 2017

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (ESTIMATE)

September 25, 2015

Study Record Updates

Last Update Posted (ACTUAL)

June 26, 2018

Last Update Submitted That Met QC Criteria

June 22, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VP-VEC-162-0101

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.

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