Sleep and Pain in Sickle Cell Disease

Johns Hopkins University

Status: Completed

Conditions: Sleep Disturbance; Sickle Cell Disease; Pain

Treatments: Other: Sickle cell disease management; Behavioral: Behavioral symptom management

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03150433

R01HL133327 (U.S. NIH Grant/Contract)

IRB00100060

Details and patient eligibility

About

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

Full 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.

Enrollment: 57 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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57 participants in 2 patient groups

Behavioral symptom management

Experimental group

Description:

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.

Treatment:

Behavioral: Behavioral symptom management

Sickle cell disease management

Other group

Description:

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.

Treatment:

Other: Sickle cell disease management