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Neurocognitive Function After Therapy of OSAS

NCT ID: NCT02505620

Last Updated: 2020-12-11

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-09-30

Brief Summary

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Obstructive Sleep Apnea Syndrome (OSAS) is characterized by repeated episodes of airway obstruction while sleeping. Upper airway obstruction while sleeping leads to a dramatic decrease in oxygen saturation and to hypoxemia finally, in which consequence the patient rapidly awake. Clinical signs are sleepiness and functional cognitive deficits. The Gold standard therapy is "continuous positive airway pressure" ventilation during sleep. However, the success depends strongly to the patient´s compliance. Surgical treatment is an alternative option, which could be considered if clinical success failed. A comparison of the cognitive function of both therapies is not yet analyzed. The study addresses the question which of this treatment options is favorable regarding cognitive function and outcome.

Detailed Description

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Obstructive Sleep Apnea Syndrome (OSAS) is characterized by repeated episodes of airway obstruction while sleeping. The "Apnea-hypopnea index" (AHI) defined as events per hour, gives information about the severity of the disease. The American Academy of Sleep Medicine Task Force" defined that more than 5 episodes per hour is strongly suspect for an OSAS disease. Upper airway obstruction while sleeping leads to a dramatic decrease in oxygen saturation and to hypoxemia finally, in which consequence the patient rapidly awake. The prevalence rise with age and about 20% of the population is suspect to a sleep disorder. However about 1-5% of male and about 0,5-2% of female aged adults are affected. Main reason is obesity. Clinical signs are sleepiness and functional cognitive deficits. The Gold standard therapy is "continuous positive airway pressure" ventilation during sleep. However, the success depends strongly to the patient´s compliance. Surgical treatment is an alternative option, which could be considered if clinical success failed. It is notable that the long-term mortality is comparable in both medical treatment options. However, a comparison of the cognitive function of both therapies is not yet analyzed. The study addresses the question which of this treatment options is favorable regarding cognitive function and outcome.

Conditions

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Neurocognitive Function OSAS

Keywords

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Neurocognitive function OSAS

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Surgical

Surgical correction of OSAS disease

Surgical Treatment with multilevel operation

Intervention Type PROCEDURE

Surgical treatment addresses a surgical multilevel anti-obstructive operation in order to eliminate upper airway obstruction permanently.

Conservative

Conservative treatment of OSAS disease

Treatment of OSAS with CPAP mask

Intervention Type PROCEDURE

Interventional treatment addresses the treatment with a CPAP (continuous positive airway pressure) mask in oder to open patients upper airway obstructive permanently while sleep.

Interventions

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Treatment of OSAS with CPAP mask

Interventional treatment addresses the treatment with a CPAP (continuous positive airway pressure) mask in oder to open patients upper airway obstructive permanently while sleep.

Intervention Type PROCEDURE

Surgical Treatment with multilevel operation

Surgical treatment addresses a surgical multilevel anti-obstructive operation in order to eliminate upper airway obstruction permanently.

Intervention Type PROCEDURE

Other Intervention Names

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CPAP (continuous positive airway pressure) mask Surgical multilevel anti-obstructive operation

Eligibility Criteria

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Inclusion Criteria

\* Patients within 30 to 70 years of age both gender.

Exclusion Criteria

* Patients under 30 years of age or older than 70 years of age.
* Preexisting neurological, neuropsychological deficits or diseases, e.g. cerebral insult or epilepsy.
* Preexisting neurological, neuropsychological medication.
* Preexisting neuromuscular diseases.
* Alcohol - and drug abuse.
* Postoperative complications, pain and time shifts within the test protocol.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Hospital Erlangen, Dept. Anaesthesiology

Erlangen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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1

Identifier Type: -

Identifier Source: org_study_id