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N/A N=110 Randomized Single-blind Treatment

Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury

Insomnia · Traumatic Brain Injury

Enrolled (actual)
110
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Insomnia Severity Index (ISI) — -9.7; -4.72 Units on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
CBT-I (Behavioral); ABT-I (Behavioral)
Age
Pediatric, Adult, Older Adult
Sex
All
Sponsor
VA Office of Research and Development
Primary completion
Sep 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Insomnia Severity Index (ISI)
-9.7; -4.72

Summary

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).

Eligibility Criteria

Inclusion Criteria

  • Male or female Veterans of any racial or ethnic group
  • Independent Living (not in nursing home or VA Extended Care facility)
  • Diagnosis of insomnia using the Duke structured interview
  • Male or female chronic (>3 months since injury) mild Traumatic Brain Injury (mTBI).
  • 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.
  • Use of medications, drugs, herbal remedies, or hormones specifically prescribed for treating sleep disturbances is allowed as long as the dose, timing, and formulation are stable (≥ 3 weeks).
  • Subjects will be assessed for sleep apnea risk by the Berlin Questionnaire. Those with responses suggestive of high risk for apnea will be referred to Pulmonary Medicine for standard clinical screening, but will not be excluded. If subjects with obstructive sleep apnea are using CPAP, we will require stable use throughout the study.

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 working a rotating shift or an unconventional daytime shift (ending after 1700 h, expected to be rare in the age group we are studying) 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 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) 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; and 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03261674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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