Fatigue, Sleep Disorders and Endocrine Abnormalities in TBI Patients

Traumatic Brain Injury Clinical Trial

Official title:

The Relationship Between Fatigue, Sleep Disorders and Endocrine Abnormalities Following Traumatic Brain Injury

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00775775
• Other study ID #: R45303
• Status: Recruiting
• Phase: N/A
• First received: October 16, 2008
• Last updated: October 2, 2009
• Start date: May 2003
• Est. completion date: December 2009

Study information

• Verified date: October 2009
• Source: Kessler Foundation
• Contact: Anthony Lequerica, Ph.D.
• Phone: 973-324-3551
• Email: alequerica[@]kesslerfoundation.net
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study will test if patients with moderate to severe traumatic brain injuries also have endocrine abnormalities, examine any existing relationships among fatigue, depression and endocrine abnormalities, and the relationship between endocrine abnormalities, quality of life, and community integration.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Having moderate to severe TBI at least 3 months prior to enrollment. This can be demonstrated by a history of loss of consciousness, amnesia or another neurologic deficit after brain injury

• Be between the ages of 18 and 70 years

Exclusion Criteria:

• History of prior TBI, stroke, seizures, severe psychiatric disturbances (i.e., those known to influence memory performance, such as schizophrenia, bipolar disorder), or drug abuse will be excluded.

• Pregnant, nursing, or planning pregnancy during the study period.

• Dementia

• Other neurological conditions which are associated with aging and known to cause fatigue (e.g. Parkinson's Disease)

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Injuries
• Parasomnias
• Sleep Disorders
• Traumatic Brain Injury

Locations

Country	Name	City	State
United States	Kessler Foundation Research Center	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To further study the incidence of fatigue and endocrine abnormalities in an outpatient TBI population		1 year	No
Secondary	To study the relationship between fatigue and endocrine abnormalities		1 year	No