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Completed

NCT Number: NCT00464659

Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome

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".

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Laboratoire EFCR-Functional Cardio-Respiratory Exploration Laboratory

Grenoble, Isere, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Effective CPAP

Device

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

Sham CPAP

Device

Similar CPAP machine delivering a 4 cm of water pressure that was too low to suppress sleep respiratory events.

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Apr 23, 2007
Registry last updated
Dec 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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