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Sleep and Pain in Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT03150433
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : June 3, 2022
Sponsor:
Collaborators:
University of Maryland
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE May 3, 2017
First Posted Date  ICMJE May 12, 2017
Last Update Posted Date June 3, 2022
Actual Study Start Date  ICMJE November 5, 2017
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 7, 2018)		 Change in Clinical pain as assessed by the Brief Pain Inventory [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: May 10, 2017)		 Change in Clinical pain [ Time Frame: baseline to 23 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 7, 2018)
  • Change in Clinical pain as assessed by the Brief Pain Inventory [ Time Frame: 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.
  • Change in Central Sensitization Index [ Time Frame: baseline and 12 weeks ]
    Index of thermal temporal summation, mechanical temporal summation, and aftersensations
  • Change in functional connectivity/cognitive task [ Time Frame: baseline and 12 weeks ]
    Functional magnetic resonance imaging, functional connectivity during cognitive testing
Original Secondary Outcome Measures  ICMJE
 (submitted: May 10, 2017)
  • Change in Clinical pain [ Time Frame: baseline to 35 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
  • Change in Central Sensitization Index [ Time Frame: baseline to 11 weeks ]
    Index of thermal temporal summation, mechanical temporal summation, and aftersensations
  • Change in functional connectivity/cognitive task [ Time Frame: baseline to 11 weeks ]
    Functional magnetic resonance imaging, functional connectivity during cognitive testing
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sleep and Pain in Sickle Cell Disease
Official Title  ICMJE Sleep and Pain in Sickle Cell Disease
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Outcome assessors will be masked to treatment condition
Primary Purpose: Treatment
Condition  ICMJE
  • Sickle Cell Disease
  • Sleep Disturbance
  • Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Behavioral: Behavioral symptom 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.
    Intervention: Other: Sickle cell disease management
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2017)		 120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2024
Estimated Primary Completion Date June 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Claudia Campbell, PhD 410-550-7989 ccampb41@jhmi.edu
Contact: Jennifer Haythornthwaite, PhD 410-550-7000 jhaytho1@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03150433
Other Study ID Numbers  ICMJE IRB00100060
R01HL133327 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Individual participant data will not be shared with other researchers
Current Responsible Party Johns Hopkins University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Johns Hopkins University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Maryland
  • National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Claudia Campbell, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date June 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP