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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL133327 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Maryland | OTHER |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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This is a study testing the effects of behavioral sleep interventions on pain and brain function in sickle cell disease.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral symptom management | Behavioral | Individual sessions focused on behavioral and cognitive strategies for managing sleep disturbance, pain, and other symptoms of sickle cell disease |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Campbell, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins | Baltimore | Maryland | 21224 | United States |
Individual participant data will not be shared with other researchers
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D020447 | Parasomnias |
| D010146 | Pain |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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Outcome assessors will be masked to treatment condition
| Sickle cell disease management | Other | Individual sessions focused on understanding and managing sickle cell disease |
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| Change in Central Sensitization Index | Index of thermal temporal summation, mechanical temporal summation, and aftersensations | baseline and 12 weeks |
| Change in functional connectivity/cognitive task | Functional magnetic resonance imaging, functional connectivity during cognitive testing | baseline and 12 weeks |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |