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

Primary Purpose

Sickle Cell Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Polysomnography and blood sample
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sickle Cell Disease focused on measuring vaso-occlusive crisis, obstructive sleep apnea, priapism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Henri Mondor Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Nocturnal VOC

Diurnal VOC

Slightly symptomatic

Arm Description

Outcomes

Primary Outcome Measures

Percentage of patients with nocturnal desaturation and patients with OSA

Secondary Outcome Measures

Oxygen desaturation index
Minimum oxygen saturation level
Quantitative analysis of biomarkers in plasma samples
Quantitative analysis of proinflammatory and anti-inflammatory cytokines
Minimum oxygen saturation level during rapid eye movement (REM) sleep in patients with recurrent priapism and in patients who never presented priapism
Apnea-Hypopnea Index
Sleep time with arterial oxygen saturation less than 90%

Full Information

First Posted
July 27, 2015
Last Updated
May 17, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02539771
Brief Title
Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events
Acronym
DREPASOM
Official Title
Sleep Study in Adult Patients With Major Sickle Cell Disease With Paroxysmal Nocturnal Events
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
September 17, 2014 (Actual)
Primary Completion Date
April 10, 2019 (Actual)
Study Completion Date
April 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
vaso-occlusive crisis, obstructive sleep apnea, priapism

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
114 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nocturnal VOC
Arm Type
Other
Arm Title
Diurnal VOC
Arm Type
Other
Arm Title
Slightly symptomatic
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
Polysomnography and blood sample
Intervention Description
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 Outcome Measure Information:
Title
Percentage of patients with nocturnal desaturation and patients with OSA
Time Frame
at 1 year
Secondary Outcome Measure Information:
Title
Oxygen desaturation index
Time Frame
at 1 year
Title
Minimum oxygen saturation level
Time Frame
at 1 year
Title
Quantitative analysis of biomarkers in plasma samples
Time Frame
at 1 year
Title
Quantitative analysis of proinflammatory and anti-inflammatory cytokines
Time Frame
at 1 year
Title
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
Title
Apnea-Hypopnea Index
Time Frame
at 1 year
Title
Sleep time with arterial oxygen saturation less than 90%
Time Frame
at 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anoosha Habibi, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henri Mondor Hospital
City
Creteil
ZIP/Postal Code
94010
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
DATAS ARE OWNED BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

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

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