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Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00464659
First received: April 20, 2007
Last updated: December 29, 2015
Last verified: December 2015

April 20, 2007
December 29, 2015
April 2007
June 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00464659 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome
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)

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".

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).
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Memory Deficit
  • Device: Effective CPAP
    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
  • Device: Sham CPAP
    Similar CPAP machine delivering a 4 cm of water pressure that was too low to suppress sleep respiratory events.
  • Experimental: Effective CPAP treatment
    Effective Continuous Positive Airway Pressure treatment (CPAP) applied for 6 weeks
    Intervention: Device: Effective CPAP
  • Sham Comparator: Sham CPAP treatment
    Ineffective Continuous Positive Airway Pressure treatment (sham CPAP) applied for 6 weeks
    Intervention: Device: Sham CPAP

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2013
June 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00464659
0629
Yes
Yes
All individual patient data are anonymized
University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Principal Investigator: Jean-Louis JP Pépin, ProfessorPhD University Hospital, Grenoble
University Hospital, Grenoble
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP