- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02505620
Neurocognitive Function After Therapy of OSAS (203_14_B)
10. december 2020 opdateret af: University of Erlangen-Nürnberg Medical School
Neurocognitive Function After Surgical and Conservative Therapy in OSAS Patients: a Randomized Control Trial
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
80
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
-
Erlangen, Tyskland, 91054
- University Hospital Erlangen, Dept. Anaesthesiology
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
30 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Patients recruted at the University Hospital Erlangen prior surgery or conventional treatment.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Surgical
Surgical correction of OSAS disease
|
Surgical treatment addresses a surgical multilevel anti-obstructive operation in order to eliminate upper airway obstruction permanently.
Andre navne:
|
|
Conservative
Conservative treatment of OSAS disease
|
Interventional treatment addresses the treatment with a CPAP (continuous positive airway pressure) mask in oder to open patients upper airway obstructive permanently while sleep.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Neurocognitive function
Tidsramme: 4 months
|
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. september 2014
Primær færdiggørelse (Faktiske)
1. september 2016
Studieafslutning (Faktiske)
1. september 2016
Datoer for studieregistrering
Først indsendt
9. juni 2015
Først indsendt, der opfyldte QC-kriterier
20. juli 2015
Først opslået (Skøn)
22. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
11. december 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. december 2020
Sidst verificeret
1. december 2020
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 1 (Mobile Health and Wellness Program)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .