Sleep and Pain in Sickle Cell Disease

Pain Clinical Trial

Official title:

Sleep and Pain in Sickle Cell Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03150433
• Other study ID #: IRB00100060
• Secondary ID: R01HL133327
• Status: Completed
• Phase: N/A
• Start date: November 5, 2017
• Est. completion date: October 27, 2023

Study information

• Verified date: October 2023
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: October 27, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Dyssomnias
• Pain
• Parasomnias
• Sickle Cell Disease
• Sleep Disturbance

Intervention

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

Other:
• Sickle cell disease management
Individual sessions focused on understanding and managing sickle cell disease

Locations

Country	Name	City	State
United States	Johns Hopkins	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	National Heart, Lung, and Blood Institute (NHLBI), University of Maryland

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Clinical pain as assessed by the Brief Pain Inventory	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.	baseline and 24 weeks
Secondary	Change in Clinical pain as assessed by the Brief Pain Inventory	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.	baseline and 36 weeks
Secondary	Change in Central Sensitization Index	Index of thermal temporal summation, mechanical temporal summation, and aftersensations	baseline and 12 weeks
Secondary	Change in functional connectivity/cognitive task	Functional magnetic resonance imaging, functional connectivity during cognitive testing	baseline and 12 weeks