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Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome

Grenoble Alpes University Hospital Center (CHU) logo

Grenoble Alpes University Hospital Center (CHU)

Status

Completed

Conditions

Memory Deficit

Treatments

Device: Effective CPAP
Device: Sham CPAP

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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".

Full 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).

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

40 participants in 2 patient groups

Effective CPAP treatment
Experimental group
Description:
Effective Continuous Positive Airway Pressure treatment (CPAP) applied for 6 weeks
Treatment:
Device: Effective CPAP
Sham CPAP treatment
Sham Comparator group
Description:
Ineffective Continuous Positive Airway Pressure treatment (sham CPAP) applied for 6 weeks
Treatment:
Device: Sham CPAP

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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