Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome

Study Overview
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Brief Summary
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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
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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).

Official Title
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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)

Conditions
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Memory Deficit

Intervention / Treatment
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* Device: Effective CPAP
* Device: Sham CPAP


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Effective CPAP treatment<br>Effective Continuous Positive Airway Pressure treatment (CPAP) applied for 6 weeks | Device: Effective CPAP<br>* 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<br>|
| Sham Comparator: Sham CPAP treatment<br>Ineffective Continuous Positive Airway Pressure treatment (sham CPAP) applied for 6 weeks | Device: Sham CPAP<br>* Similar CPAP machine delivering a 4 cm of water pressure that was too low to suppress sleep respiratory events.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep apnea obstructive syndrome (SAOS), memory deficit, Continuous Positive Airway Pression (CPAP), Sham CPAP