Sleep and Pain in Sickle Cell Disease

NCT03150433 | Completed

• 2 other identifiers: IRB00100060R01HL133327
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sickle Cell Disease; Sleep Disturbance; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in Clinical pain as assessed by the Brief Pain Inventory

  baseline and 36 weeks

• Change in Central Sensitization Index

  baseline and 12 weeks

• Change in functional connectivity/cognitive task

  baseline and 12 weeks

Study Arms (2)

Behavioral symptom management

EXPERIMENTAL

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.

Behavioral: Behavioral symptom management

Sickle cell disease management

OTHER

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.

Other: Sickle cell disease management

Interventions

Behavioral symptom management BEHAVIORAL

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

Behavioral symptom management

Sickle cell disease management OTHER

Individual sessions focused on understanding and managing sickle cell disease

Sickle cell disease management

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cognitive impairment;
• Unstable psychiatric disorder;
• Seizure disorder;
• Positive pregnancy or drug test

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Maryland: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Johns Hopkins

Baltimore, Maryland, 21224, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Parasomnias; Pain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia Campbell, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be masked to treatment condition
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 12, 2017
• Study Start: November 5, 2017
• Primary Completion: June 30, 2023
• Study Completion: October 27, 2023
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)