Pain, Sickle Cell Disease, Sleep Disturbance
Conditions
Brief summary
This is a study testing the effects of behavioral sleep interventions on pain and brain function in sickle cell disease.
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
BEHAVIORALBehavioral symptom management
Individual sessions focused on behavioral and cognitive strategies for managing sleep disturbance, pain, and other symptoms of sickle cell disease
OTHERSickle cell disease management
Individual sessions focused on understanding and managing sickle cell disease
Sponsors
University of Maryland
National Heart, Lung, and Blood Institute (NHLBI)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome assessors will be masked to treatment condition
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical pain as assessed by the Brief Pain Inventory | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical pain as assessed by the Brief Pain Inventory | 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 | baseline and 12 weeks | Index of thermal temporal summation, mechanical temporal summation, and aftersensations |
| Change in functional connectivity/cognitive task | baseline and 12 weeks | Functional magnetic resonance imaging, functional connectivity during cognitive testing |
Countries
United States
Outcome results
None listed