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Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome
This study is not yet open for participant recruitment.
Verified by University Hospital, Grenoble, January 2007
Sponsored by: University Hospital, Grenoble
Information provided by: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00464659
  Purpose

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".


Condition
Memory Deficit

MedlinePlus related topics: Memory Sleep Apnea
U.S. FDA Resources
Study Type: Observational
Study Design: Longitudinal, Random Sample, Prospective Study
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)

Further study details as provided by University Hospital, Grenoble:

Estimated Enrollment: 40
Study Start Date: April 2007
Estimated Study Completion Date: January 2008
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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00464659

Contacts
Contact: Jean-Louis JP PEPIN, ProfessorPhD 00330476765516 JPepin@chu-grenoble.fr

Locations
France, Isere
Laboratoire EFCR-Functional Cardio-Respiratory Exploration Laboratory
Grenoble, Isere, France
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Louis JP Pépin, ProfessorPhD University Hospital, Grenoble
  More Information

Publications:
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. Review.
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. Review.
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. No abstract available.
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 1;29(4):533-44.

Study ID Numbers: 0629
Study First Received: April 20, 2007
Last Updated: April 20, 2007
ClinicalTrials.gov Identifier: NCT00464659  
Health Authority: France: Afssaps - French Health Products Safety Agency

Keywords provided by University Hospital, Grenoble:
Sleep apnea obstructive syndrome (SAOS)
memory deficit
Continuous Positive Airway Pression (CPAP)
Sham CPAP

Study placed in the following topic categories:
Signs and Symptoms
Sleep Apnea Syndromes
Respiratory Tract Diseases
Apnea
Respiration Disorders
Sleep Apnea, Obstructive
 Neurologic Manifestations
Dyssomnias
Sleep Disorders
Neurobehavioral Manifestations
Memory Disorders
Sleep Disorders, Intrinsic

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on February 12, 2009



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