Sleep and Pain in Sickle Cell Disease

Not Applicable

Completed

• Conditions: Sickle Cell Disease; Sleep Disturbance; Pain
• Interventions: Behavioral: Behavioral symptom management; Other: Sickle cell disease management

• Registration Number: NCT03150433
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2017-05-03
• Study First Submitted QC: 2017-05-10
• Study First Posted: 2017-05-12
• Study Start: 2017-11-05
• Primary Completion: 2023-06-30
• Study Completion: 2023-10-27
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral symptom management	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.
Sickle cell disease management	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Johns Hopkins; 🇺🇸 Baltimore, Maryland, United States