An Observational Study to Investigate the Effects of Rapid Transmeridian Travel
Completed
- Conditions
- Jet Lag Disorder
- Interventions
- Other: Transmeridian travel across multiple time zones
- Registration Number
- NCT02560103
- Lead Sponsor
- Vanda Pharmaceuticals
- Brief Summary
Observational study to investigate circadian rhythm patterns
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 119
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Single group Transmeridian travel across multiple time zones No treatment
- Primary Outcome Measures
Name Time Method Effects of transmeridian travel on nighttime sleep after transmeridian travel measured by Polysomnography (PSG) 4 days Karolinska Sleepiness Scale (KSS) in subjects who experienced rapid transmeridian travel. 4 days
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
The Center for Sleep & Wake Disorders
🇺🇸Chevy Chase, Maryland, United States
Santa Monica Clinical Trials
🇺🇸Santa Monica, California, United States