Sleep and Pain in Sickle Cell Disease

NCT ID: NCT03150433

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-05
• Study Completion Date: 2023-10-27

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.

Conditions

Sickle Cell Disease; Sleep Disturbance; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Behavioral symptom management

Intervention Type: BEHAVIORAL

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

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.

Group Type: OTHER

Sickle cell disease management

Intervention Type: OTHER

Individual sessions focused on understanding and managing sickle cell disease

Interventions

Behavioral symptom management

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

Intervention Type: BEHAVIORAL

Sickle cell disease management

Individual sessions focused on understanding and managing sickle cell disease

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Maryland

OTHER

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Claudia Campbell, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

R01HL133327

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00100060

Identifier Type: -

Identifier Source: org_study_id