Clinical trial NCT03150433: Sleep and Pain in Sickle Cell Disease
Official title: Sleep and Pain in Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Sleep Disturbance
Pain
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: University of Maryland
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-05-12
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Clinical pain as assessed by the Brief Pain Inventory
timeFrame: baseline and 24 weeks
Secondary outcomes:
measure: Change in Clinical pain as assessed by the Brief Pain Inventory
timeFrame: baseline and 36 weeks
measure: Change in Central Sensitization Index
timeFrame: baseline and 12 weeks
measure: Change in functional connectivity/cognitive task
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Claudia Campbell, PhD
role: PRINCIPAL_INVESTIGATOR
References: