An Observational Study to Investigate the Effects of Rapi... | NCT02560103

Studies
An Observational Study to Investigate the Effects of Rapid Transmeridian Travel

NCT02560103

Sponsor

Vanda Pharmaceuticals

Status

Completed

Last Update Posted

Jun 26, 2018Actual

Enrollment

119Actual

Phase

Not provided

Conditions

Jet Lag Disorder

Interventions

Transmeridian travel across multiple time zones

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2015

Primary Completion Date

Oct 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Sep 21, 2015

First Submission Date that Met QC Criteria

Sep 23, 2015

First Posted Date

Sep 25, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2018

Last Update Posted Date

Jun 26, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

119Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Single group		No treatment	Other: Transmeridian travel across multiple time zones

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Transmeridian travel across multiple time zones	Other		Single group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Santa Monica Clinical Trials		Santa Monica	California	90404	United States
The Center for Sleep & Wake Disorders