An Observational Study to Investigate the Effects of Rapid Transmeridian Travel

• Sponsor: Vanda Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02560103
• Collaborator: (none)
• Enrollment: 119
• Locations: 2
• Duration (Months): 25
• Patients Per Site: 59.5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

Observational study to investigate circadian rhythm patterns

Condition or Disease	Intervention/Treatment	Phase
Jet Lag Disorder	Other: Transmeridian travel across multiple time zones

Study Design

• Study Type: Observational
• Actual Enrollment: 119 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: An Observational Study to Investigate the Effects of Rapid Travel
• Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: Oct 1, 2017
• Actual Study Completion Date: Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Single group No treatment	Other: Transmeridian travel across multiple time zones

Outcome Measures

Primary Outcome Measures

1. Effects of transmeridian travel on nighttime sleep after transmeridian travel measured by Polysomnography (PSG) [4 days]

2. Karolinska Sleepiness Scale (KSS) in subjects who experienced rapid transmeridian travel. [4 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Santa Monica Clinical Trials	Santa Monica	California	United States	90404
2	The Center for Sleep & Wake Disorders	Chevy Chase	Maryland	United States	20815

Sponsors and Collaborators

• Vanda Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vanda Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT02560103
• Other Study ID Numbers: VP-VEC-162-0101
• First Posted: Sep 25, 2015
• Last Update Posted: Jun 26, 2018
• Last Verified: Jun 1, 2018

• Additional relevant MeSH terms: Jet Lag Syndrome

Study Results

No Results Posted as of Jun 26, 2018