Palo Alto, California 94304

  • Traumatic Brain Injury

Purpose:

The purpose of this clinical trial is to assess the relative efficacy of two non-pharmacological interventions for insomnia in Veterans suffering from chronic mild traumatic brain injury (mTBI).


Study summary:

Insomnia is a serious health problem in Veterans suffering from chronic Traumatic Brain Injury (TBI) and often associated with extensive prescription of sleeping medications. Although safer, even the latest "sleeping pills" can lead to daytime impairment and risk of abuse. Thus non-pharmacological treatments for insomnia have been pursued as alternatives to medications. This trial will compare the relative efficacy of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Arousal-Based Therapy for Insomnia (ABT-I).


Criteria:

Inclusion Criteria: - Male or female chronic (> 3 months since injury) mTBI Veterans of any racial or ethnic group - Independent Living (not in nursing home or VA Extended Care facility) - Current chronic (3 months) subjective complaint of insomnia according to DUKE/DSM-5 criteria - Subjects with PTSD will be included in this study as long as they do not meet criteria for depression described below - Use of CNS active medications that could significantly impact sleep or alertness is allowed as long as the dose, timing, and formulation are stable (3 weeks) - Stable adult onset diabetes, controlled with insulin, oral medications or diet is acceptable Exclusion Criteria: Sleep-Related - Excessive caffeine consumption (5 cups of coffee per day) and unable to reduce to 3 cups before lunch a day for 3 weeks prior to treatment - Subjects will be initially screened by the Berlin Questionnaire (for sleep apnea) and those with responses suggestive of high risk for sleep apnea, will be referred to Pulmonary Medicine for standard clinical screening including polysomnography. - Subjects who have Obstructive Sleep Apnea (OSA) but who are adherent to CPAP will not be excluded - Subjects working a rotating shift or an unconventional daytime shift (ending after 1700 h) will be ineligible Neuropsychiatric - Current or lifetime history of a psychiatric disorder with primary psychotic features - Current or lifetime bipolar disorder; prominent suicidal or homicidal ideation - Current exposure to trauma, or exposure to trauma in the past 3 months - Current or within the past 30 days: drug abuse or dependence (except nicotine) - Current or expected cognitive behavior therapy for another condition (e.g. depression) - More than one glass of wine or beer with dinner scheduled at least 3 to 4 hours before bedtime - Presence of any acute or unstable psychiatric condition(s) that requires referral for treatment - Folstein Mini-Mental State Exam (MMSE) < 24 or TCogs < 23 Medical - Acute or unstable chronic illness, including but not limited to: - uncontrolled thyroid disease - kidney - prostate or bladder conditions causing excessively frequent urination (> 3 times per night) - medically unstable congestive heart failure - angina - other severe cardiac illness as defined by treatment regimen changes in the prior 3 months - stroke with serious sequelae - cancer if < 1 year since end of treatment - asthma - emphysema - or other severe respiratory diseases uncontrolled with medications - neurological disorders such as Alzheimer's disease, Parkinson's disease and unstable epilepsy as defined by treatment regimen changes in the prior 3 months - Unstable adult onset diabetes will be excluded


NCT ID:

NCT03261674


Primary Contact:

Principal Investigator
Ansgar J. Furst, PhD
VA Palo Alto Health Care System, Palo Alto, CA

Rayma Williams, BS
Phone: (650) 852-3426
Email: rayma.williams@va.gov


Backup Contact:

Email: Ansgar.Furst@va.gov
Ansgar J Furst, PhD
Phone: (650) 493-5000 ext. 68652


Location Contact:

Palo Alto, California 94304
United States

Ansgar J Furst, PhD
Phone: 650-493-5000
Email: Ansgar.Furst@va.gov

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 18, 2021

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