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NCT Number: NCT02539771

Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events

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.

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Apnea Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dyssomnias Genetic Diseases, Inborn Genital Diseases Genital Diseases, Male Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies Male Urogenital Diseases Nervous System Diseases Penile Diseases Priapism Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Urogenital Diseases Vaso-Occlusive Crises

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henri Mondor Hospital

Créteil, 94010, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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
  • written informed consent

Slightly symptomatic group:

  • no hospitalization for VOC
  • written informed consent

Exclusion criteria

  • 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
  • Inactive affiliation to social security
  • Under legal protection
  • A female who is pregnant or breastfeeding
  • Prisoners
  • Emergency situation
  • Refusing to participate in the study

Treatment and study plan

Polysomnography and blood sample

Other

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 "

Primary outcomes

  1. Percentage of patients with nocturnal desaturation and patients with OSA

    Time frame: at 1 year

Secondary outcomes

  1. Oxygen desaturation index

    Time frame: at 1 year

  2. Minimum oxygen saturation level

    Time frame: at 1 year

  3. Quantitative analysis of biomarkers in plasma samples

    Time frame: at 1 year

  4. Quantitative analysis of proinflammatory and anti-inflammatory cytokines

    Time frame: at 1 year

  5. 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

  6. Apnea-Hypopnea Index

    Time frame: at 1 year

  7. Sleep time with arterial oxygen saturation less than 90%

    Time frame: at 1 year

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: DREPASOM

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Sep 3, 2015
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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