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Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome

Primary Purpose

Memory Deficit

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Effective CPAP
Sham CPAP
Sponsored by
University Hospital, Grenoble
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Memory Deficit focused on measuring Sleep apnea obstructive syndrome (SAOS), memory deficit, Continuous Positive Airway Pression (CPAP), Sham CPAP

Eligibility Criteria

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

Inclusion Criteria:

  • Major patients,
  • agreeing,
  • diagnosed suffering from the SAOS,
  • regulation by the specialist in a treatment by CPAP,
  • patients do not begin the treatment
  • affiliated to the social security,
  • fluent in French.

Exclusion Criteria:

  • Patients presenting severe depressive disorders (HADS score>19),
  • intellectual deterioration (MMS< 28),
  • a functional failure of the dominant arm upper limb inhibiting realization of graphic tasks,
  • an associated oxygen treatment,
  • suffering from cancer,
  • cerebro-vascular accident,
  • pregnant or nursing women,
  • adult under supervision or trusteeship,
  • patients already included in another research protocol or in period of exclusion,
  • antidepressant and anxiolytic treatment.

Sites / Locations

  • Laboratoire EFCR-Functional Cardio-Respiratory Exploration Laboratory

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Effective CPAP treatment

Sham CPAP treatment

Arm Description

Effective Continuous Positive Airway Pressure treatment (CPAP) applied for 6 weeks

Ineffective Continuous Positive Airway Pressure treatment (sham CPAP) applied for 6 weeks

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 20, 2007
Last Updated
December 29, 2015
Sponsor
University Hospital, Grenoble
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1. Study Identification

Unique Protocol Identification Number
NCT00464659
Brief Title
Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome
Official Title
Comparison of the Evolution of Memory Deficit in Patients With Sleep Apnea Obstructive Syndrome (SAOS) Before and After "Effective" Versus Sham Treatment by Positive Pression Continues (PPC)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main objective of this study is to evaluate the evolution of memory deficit (verbal episodic memory, procedural memory, working memory, short-term memory) in Sleep Apnea Obstructive Syndrome (SAOS) patients after treatment by Continuous Positive Airway Pressure treatment (CPAP). For thus, we will compare memory tests in two separate groups of SAOS patients with "effective " versus "ineffective" ( or sham) CPAP, before and 6 weeks after the beginning of the treatment. Thus we will assess the evolution of memory deficit, the effectiveness of the treatment on the evolution of memory deficit before and 6 weeks after the beginning of the treatment by "effective " versus "ineffective" CPAP. We feel the results of the tests of memory will show greater memory disorders in patients with SAOS before beginning the treatment rather than six weeks afterwards. Thus we hypothesise that, after the treatment by "effective" CPAP, the patients with SAOS will have greater improvement of their memory disorders than those treated by "sham CPAP".
Detailed Description
We want to assess the evolution, before and 6 weeks after the beginning of the treatment, of the significant differences of the performances of the various memory tests evaluating several forms of memory (episodic memory, working memory, short-term memory and procedural memory) according to the treatment for patients with SAOS (effective versus sham).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Memory Deficit
Keywords
Sleep apnea obstructive syndrome (SAOS), memory deficit, Continuous Positive Airway Pression (CPAP), Sham CPAP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Effective CPAP treatment
Arm Type
Experimental
Arm Description
Effective Continuous Positive Airway Pressure treatment (CPAP) applied for 6 weeks
Arm Title
Sham CPAP treatment
Arm Type
Sham Comparator
Arm Description
Ineffective Continuous Positive Airway Pressure treatment (sham CPAP) applied for 6 weeks
Intervention Type
Device
Intervention Name(s)
Effective CPAP
Intervention Description
Auto-titrating CPAP machines (Remstar Auto; Philips Respironics, Murrysville, PA) provided by a home care company (Bastide Medical, France). Pressure was set between 6 and 14 cm of water
Intervention Type
Device
Intervention Name(s)
Sham CPAP
Intervention Description
Similar CPAP machine delivering a 4 cm of water pressure that was too low to suppress sleep respiratory events.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Major patients, agreeing, diagnosed suffering from the SAOS, regulation by the specialist in a treatment by CPAP, patients do not begin the treatment affiliated to the social security, fluent in French. Exclusion Criteria: Patients presenting severe depressive disorders (HADS score>19), intellectual deterioration (MMS< 28), a functional failure of the dominant arm upper limb inhibiting realization of graphic tasks, an associated oxygen treatment, suffering from cancer, cerebro-vascular accident, pregnant or nursing women, adult under supervision or trusteeship, patients already included in another research protocol or in period of exclusion, antidepressant and anxiolytic treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Louis JP Pépin, ProfessorPhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laboratoire EFCR-Functional Cardio-Respiratory Exploration Laboratory
City
Grenoble
State/Province
Isere
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All individual patient data are anonymized
Citations:
PubMed Identifier
11869421
Citation
Beebe DW, Gozal D. Obstructive sleep apnea and the prefrontal cortex: towards a comprehensive model linking nocturnal upper airway obstruction to daytime cognitive and behavioral deficits. J Sleep Res. 2002 Mar;11(1):1-16. doi: 10.1046/j.1365-2869.2002.00289.x.
Results Reference
background
PubMed Identifier
15223874
Citation
Engleman HM, Douglas NJ. Sleep. 4: Sleepiness, cognitive function, and quality of life in obstructive sleep apnoea/hypopnoea syndrome. Thorax. 2004 Jul;59(7):618-22. doi: 10.1136/thx.2003.015867.
Results Reference
background
PubMed Identifier
10209985
Citation
Farre R, Hernandez L, Montserrat JM, Rotger M, Ballester E, Navajas D. Sham continuous positive airway pressure for placebo-controlled studies in sleep apnoea. Lancet. 1999 Apr 3;353(9159):1154. doi: 10.1016/S0140-6736(99)01056-9. No abstract available.
Results Reference
background
PubMed Identifier
16676787
Citation
Naegele B, Launois SH, Mazza S, Feuerstein C, Pepin JL, Levy P. Which memory processes are affected in patients with obstructive sleep apnea? An evaluation of 3 types of memory. Sleep. 2006 Apr;29(4):533-44. doi: 10.1093/sleep/29.4.533.
Results Reference
background
PubMed Identifier
27810185
Citation
Joyeux-Faure M, Naegele B, Pepin JL, Tamisier R, Levy P, Launois SH. Continuous positive airway pressure treatment impact on memory processes in obstructive sleep apnea patients: a randomized sham-controlled trial. Sleep Med. 2016 Aug;24:44-50. doi: 10.1016/j.sleep.2016.06.023. Epub 2016 Aug 23.
Results Reference
derived
PubMed Identifier
26567858
Citation
Jullian-Desayes I, Tamisier R, Zarski JP, Aron-Wisnewsky J, Launois-Rollinat SH, Trocme C, Levy P, Joyeux-Faure M, Pepin JL. Impact of effective versus sham continuous positive airway pressure on liver injury in obstructive sleep apnoea: Data from randomized trials. Respirology. 2016 Feb;21(2):378-85. doi: 10.1111/resp.12672. Epub 2015 Nov 16.
Results Reference
derived

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Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome

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