Sleep and Pain in Sickle Cell Disease

Overview

This is a study testing the effects of behavioral sleep interventions on pain and brain function in sickle cell disease.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: May 31, 2022

Detailed Description

The investigators propose to examine whether changes in sleep alter pain and pain-related outcomes in adults with Sickle Cell Disease (SCD). As many as 70% of adults with SCD experience various sleep disturbances. Pain and sleep are inter-related, such that pain disturbs sleep and disturbed sleep amplifies pain and increases risk for developing chronic pain. Pain processing occurs in the central nervous system, where nociceptive input can be inhibited or facilitated and which can undergo both functional and structural plasticity. When plasticity results in amplification of pain, this central sensitization (CS) manifests as hyperalgesia, allodynia, and spreading of pain and is an important treatment target in its own right. A growing literature implicates central sensitization in SCD, and the investigators find a strong association between laboratory-evoked CS and sleep disturbance in SCD. The neural substrates involved in pain modulation are often disrupted in chronic pain, likely due to the demands pain places on cognitive resources, and similar effects are seen with chronic insomnia. It remains unclear whether these changes occur in SCD and if improving sleep improves central modulation of pain. The potential for improved sleep to reduce pain and CS requires additional investigation, particularly given the significance of sleep disturbance as a mutable risk factor. The investigators will conduct a randomized trial in which it will be determined whether improvements in sleep reduce pain and alter brain processing of pain and cognitive stimuli. The aims are to determine whether treatment of sleep improves pain outcomes in SCD and to determine whether treatment of sleep alters functional connectivity of cognitive and pain modulatory networks using brain imaging in SCD.

Interventions

  • Behavioral: Behavioral symptom management
    • Individual sessions focused on behavioral and cognitive strategies for managing sleep disturbance, pain, and other symptoms of sickle cell disease
  • Other: Sickle cell disease management
    • Individual sessions focused on understanding and managing sickle cell disease

Arms, Groups and Cohorts

  • Experimental: Behavioral symptom management
    • Five sessions working one-on-one with a study interventionist, either in person or by telephone. Includes monitoring of the individual’s sleep pattern, feedback and goals for improving sleep and pain management, and addressing cognitive and emotional strategies for managing sleep and pain.
  • Other: Sickle cell disease management
    • Five sessions working one-on-one with a study interventionist, either in person or by telephone. Includes monitoring of the individual’s sleep pattern, information about sickle cell disease and its management, and information about improving sleep and managing pain.

Clinical Trial Outcome Measures

Primary Measures

  • Change in Clinical pain as assessed by the Brief Pain Inventory
    • Time Frame: baseline and 24 weeks
    • Average of 4 items from the Brief Pain Inventory; each rated on a 0 (no pain) to 10 (pain as bad as you can imagine); ratings are made of pain right now, typical pain, worst pain, and least pain during the past week. Total sub-score of 0-40 with higher score indicating more pain.

Secondary Measures

  • Change in Clinical pain as assessed by the Brief Pain Inventory
    • Time Frame: baseline and 36 weeks
    • Average of 4 items from the Brief Pain Inventory; each rated on a 0 (no pain) to 10 (pain as bad as you can imagine); ratings are made of pain right now, typical pain, worst pain, and least pain during the past week. Total sub-score of 0-40 with higher score indicating more pain.
  • Change in Central Sensitization Index
    • Time Frame: baseline and 12 weeks
    • Index of thermal temporal summation, mechanical temporal summation, and aftersensations
  • Change in functional connectivity/cognitive task
    • Time Frame: baseline and 12 weeks
    • Functional magnetic resonance imaging, functional connectivity during cognitive testing

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of sickle cell hemoglobinopathy (Homozygous sickle cell disease, Hemoglobin SC disease, or Sickle/beta-thalassemia); – Adequate facility with English; – Stable dosing of medications (if taking) for pain and sleep; – Reports symptoms of insomnia; – Reports chronic pain Exclusion Criteria:

  • Cognitive impairment; – Unstable psychiatric disorder; – Seizure disorder; – Positive pregnancy or drug test

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 100 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Johns Hopkins University
  • Collaborator
    • University of Maryland, College Park
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Claudia Campbell, PhD, Principal Investigator, Johns Hopkins University
  • Overall Contact(s)
    • Claudia Campbell, PhD, 410-550-7989, ccampb41@jhmi.edu

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