Sickle Cell DiseaseNCT03150433
Sleep and Pain in Sickle Cell Disease
A study testing Behavioral symptom management and Sickle cell disease management in people with Sickle Cell Disease and Sleep Disturbance, run by Johns Hopkins University at 1 site in United States.
Trial summary
This is a study testing the effects of behavioral sleep interventions on pain and brain function in sickle cell disease. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Sickle Cell Disease, Sleep Disturbance, Pain
- What is being tested?
- Behavioral symptom management and Sickle cell disease management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Nov 2017to 27 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cognitive impairment;
- Unstable psychiatric disorder;
- Seizure disorder;
- Positive pregnancy or drug test
Trial locations and contacts
1 site in 1 country.
About this study
This is a study testing the effects of behavioral sleep interventions on pain and brain function in sickle cell disease.
Read the 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
- Being tested
- Behavioral symptom management, Sickle cell disease management
- Medical subject headings
- Anemia, Sickle Cell, Parasomnias, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral symptom managementBehavioural
Individual sessions focused on behavioral and cognitive strategies for managing sleep disturbance, pain, and other symptoms of sickle cell disease
Sickle cell disease managementOther
Individual sessions focused on understanding and managing sickle cell disease
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Sickle cell disease management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 24 weeks
Secondary outcomes (3)
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.
Measured: baseline and 36 weeks
Change in Central Sensitization Index
Index of thermal temporal summation, mechanical temporal summation, and aftersensations
Measured: baseline and 12 weeks
Change in functional connectivity/cognitive task
Functional magnetic resonance imaging, functional connectivity during cognitive testing
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2017
- Study start5 Nov 2017
- Primary completion30 Jun 2023
- Study completion27 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Claudia Campbell, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03150433
- Sponsor's protocol ID
- IRB00100060
- Other IDs
- R01HL133327
- Status last verified
- Jan 2025
- First submitted
- 3 May 2017
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep and Pain in Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT03150433
- Acronym / sponsor ID
- IRB00100060
- Conditions
- Sickle Cell Disease, Sleep Disturbance, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- University of Maryland, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 5 Nov 2017 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 27 Oct 2023 (actual)
- First posted
- 12 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral symptom management | Experimental | Behavioral: Behavioral symptom managementFive 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. |
| Sickle cell disease management | Other | Other: Sickle cell disease managementFive 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Cognitive impairment;
- Unstable psychiatric disorder;
- Seizure disorder;
- Positive pregnancy or drug test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral symptom managementIndividual sessions focused on behavioral and cognitive strategies for managing sleep disturbance, pain, and other symptoms of sickle cell disease | Behavioural | Behavioral symptom management |
| Sickle cell disease managementIndividual sessions focused on understanding and managing sickle cell disease | Other | Sickle cell disease management |
Primary outcome
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.
3 secondary outcomes
Change in Clinical pain as assessed by the Brief Pain Inventory
Time frame: baseline and 36 weeks
Change in Central Sensitization Index
Time frame: baseline and 12 weeks
Change in functional connectivity/cognitive task
Time frame: baseline and 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Campbell, PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral symptom management and Sickle cell disease management in people with Sickle Cell Disease and Sleep Disturbance, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Clinical pain as assessed by the Brief Pain Inventory (time frame: baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.