Protocol Memory Deficit in Patients With Obstructive Sleep Apnea Syndrome
NCT ID: NCT00464659
Last Updated: 2015-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2007-04-30
2013-06-30
Brief Summary
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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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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Effective CPAP treatment
Effective Continuous Positive Airway Pressure treatment (CPAP) applied for 6 weeks
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
Sham CPAP treatment
Ineffective Continuous Positive Airway Pressure treatment (sham CPAP) applied for 6 weeks
Sham CPAP
Similar CPAP machine delivering a 4 cm of water pressure that was too low to suppress sleep respiratory events.
Interventions
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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
Sham CPAP
Similar CPAP machine delivering a 4 cm of water pressure that was too low to suppress sleep respiratory events.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Responsible Party
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Principal Investigators
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Jean-Louis JP Pépin, ProfessorPhD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Grenoble
Locations
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Laboratoire EFCR-Functional Cardio-Respiratory Exploration Laboratory
Grenoble, Isere, France
Countries
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References
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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. doi: 10.1046/j.1365-2869.2002.00289.x.
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. doi: 10.1136/thx.2003.015867.
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. doi: 10.1016/S0140-6736(99)01056-9. 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;29(4):533-44. doi: 10.1093/sleep/29.4.533.
Joyeux-Faure M, Naegele B, Pepin JL, Tamisier R, Levy P, Launois SH. Continuous positive airway pressure treatment impact on memory processes in obstructive sleep apnea patients: a randomized sham-controlled trial. Sleep Med. 2016 Aug;24:44-50. doi: 10.1016/j.sleep.2016.06.023. Epub 2016 Aug 23.
Jullian-Desayes I, Tamisier R, Zarski JP, Aron-Wisnewsky J, Launois-Rollinat SH, Trocme C, Levy P, Joyeux-Faure M, Pepin JL. Impact of effective versus sham continuous positive airway pressure on liver injury in obstructive sleep apnoea: Data from randomized trials. Respirology. 2016 Feb;21(2):378-85. doi: 10.1111/resp.12672. Epub 2015 Nov 16.
Other Identifiers
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0629
Identifier Type: -
Identifier Source: org_study_id