Neurocognitive Function After Therapy of OSAS

Neurocognitive Function Clinical Trial

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Official title:

Neurocognitive Function After Surgical and Conservative Therapy in OSAS Patients: a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02505620
• Other study ID #: 1
• Status: Completed
• Start date: September 2014
• Est. completion date: September 2016

Study information

• Verified date: December 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Neurocognitive Function
• OSAS

Intervention

Procedure:
• 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.
• Surgical Treatment with multilevel operation
Surgical treatment addresses a surgical multilevel anti-obstructive operation in order to eliminate upper airway obstruction permanently.

Locations

Country	Name	City	State
Germany	University Hospital Erlangen, Dept. Anaesthesiology	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive function	Using different tests addressing a various quality of neurocognitive function (attention, memory, perceptual and processing speed, alertness and executive function) participants score test appropriate values. Comparing test values separately allows to distinguish between prior - and post - operative and prior and post - interventional status. Moreover it allows to discriminate achieved test results between both groups and calculate statistical differences. Favorable test results lead to a potential better neurocognitive function outcome and enable to assess neurocognitive function in the light of operation or interventional consequence.	4 months