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Completed

NCT Number: NCT02560103

An Observational Study to Investigate the Effects of Rapid Transmeridian Travel

Observational study to investigate circadian rhythm patterns

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Key information

Conditions

Jet Lag Disorder

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Santa Monica Clinical Trials, Santa Monica, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transmeridian travel across multiple time zones

Other

Primary outcomes

  1. Effects of transmeridian travel on nighttime sleep after transmeridian travel measured by Polysomnography (PSG)

    Time frame: 4 days

  2. Karolinska Sleepiness Scale (KSS) in subjects who experienced rapid transmeridian travel.

    Time frame: 4 days

Sponsors and collaborators

Lead sponsor

Vanda Pharmaceuticals

Industry

Registry information

Official study title

An Observational Study to Investigate the Effects of Rapid Travel

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 25, 2015
Registry last updated
Jun 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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