Sleep and Pain in Sickle Cell Disease
Primary Purpose
Sickle Cell Disease, Sleep Disturbance, Pain
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Behavioral symptom management
Sickle cell disease management
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease
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
Sites / Locations
- Johns HopkinsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Behavioral symptom management
Sickle cell disease management
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Change in Central Sensitization Index
Index of thermal temporal summation, mechanical temporal summation, and aftersensations
Change in functional connectivity/cognitive task
Functional magnetic resonance imaging, functional connectivity during cognitive testing
Full Information
NCT ID
NCT03150433
First Posted
May 3, 2017
Last Updated
September 7, 2023
Sponsor
Johns Hopkins University
Collaborators
University of Maryland, National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT03150433
Brief Title
Sleep and Pain in Sickle Cell Disease
Official Title
Sleep and Pain in Sickle Cell Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 5, 2017 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
University of Maryland, National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease, Sleep Disturbance, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be masked to treatment condition
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Behavioral symptom management
Arm Type
Experimental
Arm 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.
Arm Title
Sickle cell disease management
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioral symptom management
Intervention Description
Individual sessions focused on behavioral and cognitive strategies for managing sleep disturbance, pain, and other symptoms of sickle cell disease
Intervention Type
Other
Intervention Name(s)
Sickle cell disease management
Intervention Description
Individual sessions focused on understanding and managing sickle cell disease
Primary Outcome Measure Information:
Title
Change in Clinical pain as assessed by the Brief Pain Inventory
Description
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.
Time Frame
baseline and 24 weeks
Secondary Outcome Measure Information:
Title
Change in Clinical pain as assessed by the Brief Pain Inventory
Description
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.
Time Frame
baseline and 36 weeks
Title
Change in Central Sensitization Index
Description
Index of thermal temporal summation, mechanical temporal summation, and aftersensations
Time Frame
baseline and 12 weeks
Title
Change in functional connectivity/cognitive task
Description
Functional magnetic resonance imaging, functional connectivity during cognitive testing
Time Frame
baseline and 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Campbell, PhD
Phone
410-550-7989
Email
ccampb41@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Haythornthwaite, PhD
Phone
410-550-7000
Email
jhaytho1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Campbell, PhD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jim Stone
Phone
410-550-7906
Email
jstone8@jhmi.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data will not be shared with other researchers
Learn more about this trial
Sleep and Pain in Sickle Cell Disease
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