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Completed

NCT Number: NCT03150433

Sleep and Pain in Sickle Cell Disease

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Behavioral symptom management

Behavioral

Individual sessions focused on behavioral and cognitive strategies for managing sleep disturbance, pain, and other symptoms of sickle cell disease

Sickle cell disease management

Other

Individual sessions focused on understanding and managing sickle cell disease

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Change in Central Sensitization Index

    Time frame: baseline and 12 weeks

    Index of thermal temporal summation, mechanical temporal summation, and aftersensations

  3. Change in functional connectivity/cognitive task

    Time frame: baseline and 12 weeks

    Functional magnetic resonance imaging, functional connectivity during cognitive testing

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Maryland

Registry information

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
May 12, 2017
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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