Sickle Cell DiseaseDREPASOMNCT02539771
Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events
A study testing Polysomnography and blood sample in people with Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Hypothesis is that the occurrence of nocturnal Vaso-Occlusive Crisis (VOC) and priapism in adults might be related to episodes of nocturnal desaturation secondary to a sleep apnea syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- Polysomnography and blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2014to 10 Apr 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Night VOC Group:
- night VOC ≥ 2 in the previous year
- written informed consent
- Daytime VOC Group:
- VOC no nocturnal
- diurnal VOC ≥ 2 in the previous year
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- written informed consent
- Slightly symptomatic group:
- no hospitalization for VOC
- written informed consent
Who cannot join
- Taking opioids
- Taking medication that alters sleep (antidepressants, benzodiazepines ...)
- Known history of sleep apnea syndrome
- Known history of serious psychiatric disorder
- Recent vaso-occlusive crisis (within 3 weeks)
- Changes in background treatment (Hydrea or exchange transfusions) in the past 12 months
Show all 12Show fewer
- Inactive affiliation to social security
- Under legal protection
- A female who is pregnant or breastfeeding
- Prisoners
- Emergency situation
- Refusing to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Hypothesis is that the occurrence of nocturnal Vaso-Occlusive Crisis (VOC) and priapism in adults might be related to episodes of nocturnal desaturation secondary to a sleep apnea syndrome. Investigator hypothesize that chronic biological consequences of Obstructive Sleep Apnea (hypercoagulability, endothelial dysfunction ...) favour VOC and acute manifestations (nocturnal desaturation) favour nocturnal VOC.
The confirmation of this hypothesis will lead investigator to propose a systematic screening of obstructive sleep apnea (OSA) in patients with nocturnal VOC. Moreover, systematic treatment of OSA in sickle cell patients could help significantly reduce the number and severity of nocturnal VOC.
- Conditions
- Sickle Cell Disease
- Being tested
- Polysomnography and blood sample
- Keywords
- vaso-occlusive crisis, obstructive sleep apnea, priapism
- Medical subject headings
- Anemia, Sickle Cell, Vaso-Occlusive Crises, Sleep Apnea, Obstructive, Priapism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polysomnography and blood sampleOther
Blood collection is a specific intervention of protocol for the 3 arms. Polysomnography is a specific intervention for the arms " Diurnal VOC " and " Slightly symptomatic "
| Study group | Role | What they receive |
|---|---|---|
| Nocturnal VOC | Other | Not described Receives: Other: Polysomnography and blood sample |
| Diurnal VOC | Other | Not described Receives: Other: Polysomnography and blood sample |
| Slightly symptomatic | Other | Not described Receives: Other: Polysomnography and blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with nocturnal desaturation and patients with OSA
Measured: at 1 year
Secondary outcomes (7)
Oxygen desaturation index
Measured: at 1 year
Minimum oxygen saturation level
Measured: at 1 year
Quantitative analysis of biomarkers in plasma samples
Measured: at 1 year
Quantitative analysis of proinflammatory and anti-inflammatory cytokines
Measured: at 1 year
Minimum oxygen saturation level during rapid eye movement (REM) sleep in patients with recurrent priapism and in patients who never presented priapism
Measured: at 1 year
Apnea-Hypopnea Index
Measured: at 1 year
Sleep time with arterial oxygen saturation less than 90%
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study start17 Sep 2014
- Primary completion10 Apr 2019
- Study completion10 Apr 2019
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 Assistance Publique - Hôpitaux de ParisThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anoosha Habibi, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539771
- Sponsor's protocol ID
- P111121
- Acronym
- DREPASOM
- Status last verified
- May 2023
- First submitted
- 27 Jul 2015
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: DATAS ARE OWNED BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events
- ClinicalTrials.gov ID
- NCT02539771
- Acronym / sponsor ID
- DREPASOM / P111121
- Conditions
- Sickle Cell Disease
- Keywords
- vaso-occlusive crisis, obstructive sleep apnea, priapism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 17 Sep 2014 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 3 Sep 2015 (estimated)
- 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.
Hypothesis is that the occurrence of nocturnal Vaso-Occlusive Crisis (VOC) and priapism in adults might be related to episodes of nocturnal desaturation secondary to a sleep apnea syndrome. Investigator hypothesize that chronic biological consequences of Obstructive Sleep Apnea (hypercoagulability, endothelial dysfunction ...) favour VOC and acute manifestations (nocturnal desaturation) favour nocturnal VOC.
The confirmation of this hypothesis will lead investigator to propose a systematic screening of obstructive sleep apnea (OSA) in patients with nocturnal VOC. Moreover, systematic treatment of OSA in sickle cell patients could help significantly reduce the number and severity of nocturnal VOC.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Nocturnal VOC | Other | Other: Polysomnography and blood sample |
| Diurnal VOC | Other | Other: Polysomnography and blood sample |
| Slightly symptomatic | Other | Other: Polysomnography and blood sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- night VOC ≥ 2 in the previous year
- written informed consent
- VOC no nocturnal
- diurnal VOC ≥ 2 in the previous year
- written informed consent
Key exclusion criteria (12 listed)
- Taking opioids
- Taking medication that alters sleep (antidepressants, benzodiazepines ...)
- Known history of sleep apnea syndrome
- Known history of serious psychiatric disorder
- Recent vaso-occlusive crisis (within 3 weeks)
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 |
|---|---|---|
| Polysomnography and blood sampleBlood collection is a specific intervention of protocol for the 3 arms. Polysomnography is a specific intervention for the arms " Diurnal VOC " and " Slightly symptomatic " | Other | Diurnal VOC, Nocturnal VOC, Slightly symptomatic |
Primary outcome
Percentage of patients with nocturnal desaturation and patients with OSA
Time frame: at 1 year
7 secondary outcomes
Oxygen desaturation index
Time frame: at 1 year
Minimum oxygen saturation level
Time frame: at 1 year
Quantitative analysis of biomarkers in plasma samples
Time frame: at 1 year
Quantitative analysis of proinflammatory and anti-inflammatory cytokines
Time frame: at 1 year
Minimum oxygen saturation level during rapid eye movement (REM) sleep in patients with recurrent priapism and in patients who never presented priapism
Time frame: at 1 year
Apnea-Hypopnea Index
Time frame: at 1 year
Sleep time with arterial oxygen saturation less than 90%
Time frame: at 1 year
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 19 May 2023.
- Individual participant dataSharing planned: No. DATAS ARE OWNED BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION
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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.
Anoosha Habibi, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polysomnography and blood sample in people with Sickle Cell Disease, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 10 inclusion and 12 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 19 May 2023. 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 France. 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?
Percentage of patients with nocturnal desaturation and patients with OSA (time frame: at 1 year). 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 19 May 2023.