ID

24881

Beskrivning

Cognitive Benefits of Treating Sleep Apnea in Parkinson's Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00492115

Länk

https://clinicaltrials.gov/show/NCT00492115

Nyckelord

Versioner (1)
  1. 2017-08-21 2017-08-21 -
Uppladdad den

21 augusti 2017

DOI

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Creative Commons BY 4.0
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Eligibility Parkinson's Disease NCT00492115

Engelsk

Eligibility Parkinson's Disease NCT00492115

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of dementia due to parkinson's disease (according to the fourth edition of the diagnostic and statistical manual of mental disorders (code 294.1)
Beskrivning

Dementia due to Parkinson's disease

Datatyp

boolean

Alias
UMLS CUI [1]
C0236960
mmse score between 18 and 26, inclusive; cognitive symptoms must occur at least one year after the diagnosis of pdd
Beskrivning

Mini-mental state examination | Cognitive symptoms

Datatyp

boolean

Alias
UMLS CUI [1]
C0451306
UMLS CUI [2]
C0525041
apnea hypopnea index >10 (i.e., 10 apneas plus hypopneas per hour of sleep)
Beskrivning

Apnea-hypopnea index

Datatyp

boolean

Alias
UMLS CUI [1]
C2111846
over the age of 50 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
stable health
Beskrivning

Health Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018684
UMLS CUI [1,2]
C0205360
fluent english speaking
Beskrivning

Able to speak fluently English Language

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0564241
UMLS CUI [1,2]
C0376245
patients will be allowed to continue dopaminergic medications, acetylcholinesterase inhibitors, psychotropic medications, memory enhancers, health food supplements, etc. as long as they have been stable on the same dose for at least two months prior to participation and agree to continue on this dose for the duration of the 6-week study.
Beskrivning

Dopaminergic Agents | Acetylcholinesterase Inhibitors | Psychotropic Drugs | Nootropic Agents | Dietary Supplements | Pharmaceutical Preparations Dose Stable

Datatyp

boolean

Alias
UMLS CUI [1]
C0013036
UMLS CUI [2]
C0001046
UMLS CUI [3]
C0033978
UMLS CUI [4]
C0242913
UMLS CUI [5]
C0242295
UMLS CUI [6,1]
C0013227
UMLS CUI [6,2]
C0178602
UMLS CUI [6,3]
C0205360
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
current treatment for sleep apnea (to avoid discontinuing already established treatment for sleep apnea and any carry over confounding effect of treatment on cognition).
Beskrivning

Therapeutic procedure Sleep Apnea

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0037315
central sleep apnea
Beskrivning

Sleep Apnea, Central

Datatyp

boolean

Alias
UMLS CUI [1]
C0520680
use of medications known to influence sleep (i.e. sedative hypnotics, narcotics) if the dose cannot remain stable for the duration of the study.
Beskrivning

Pharmaceutical Preparations Affecting Sleep | Sedative hypnotics | Narcotics

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0037313
UMLS CUI [2]
C0020592
UMLS CUI [3]
C0027415
bronchospastic and symptomatic chronic obstructive pulmonary disease as indicated by regular use of bronchodilators, steroids, history of carbon dioxide retention, waking hypoxemia (pao2 <60 mmhg or spo2 <92 % by pulse oximetry), or use of supplemental oxygen.
Beskrivning

Chronic Obstructive Airway Disease Bronchial Spasm | Chronic Obstructive Airway Disease Symptomatic | Bronchodilator Agents Regular | Steroids | Hypercapnia | Hypoxemia Waking | PaO2 Pulse Oximetry | SpO2 Pulse Oximetry | Receiving supplemental oxygen

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0024117
UMLS CUI [1,2]
C0006266
UMLS CUI [2,1]
C0024117
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0006280
UMLS CUI [3,2]
C0205272
UMLS CUI [4]
C0038317
UMLS CUI [5]
C0020440
UMLS CUI [6,1]
C0700292
UMLS CUI [6,2]
C0442696
UMLS CUI [7,1]
C1822073
UMLS CUI [7,2]
C0034108
UMLS CUI [8,1]
C2317096
UMLS CUI [8,2]
C0034108
UMLS CUI [9]
C3841316
symptomatic coronary or cerebral vascular disease (history of myocardial infarction, angina, stroke, or transient ischemic attacks), history of life-threatening arrhythmias, cardiomyopathy, or current alcohol or drug abuse
Beskrivning

Cardiovascular Diseases Symptomatic | Cerebrovascular Disorders Symptomatic | Myocardial Infarction | Angina Pectoris | Cerebrovascular accident | Transient Ischemic Attack | Cardiac Arrhythmia Life Threatening | Cardiomyopathy | Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0007222
UMLS CUI [1,2]
C0231220
UMLS CUI [2,1]
C0007820
UMLS CUI [2,2]
C0231220
UMLS CUI [3]
C0027051
UMLS CUI [4]
C0002962
UMLS CUI [5]
C0038454
UMLS CUI [6]
C0007787
UMLS CUI [7,1]
C0003811
UMLS CUI [7,2]
C2826244
UMLS CUI [8]
C0878544
UMLS CUI [9]
C0038586
current diagnosis of active seizure disorder; presence of any neurodegenerative disorder other than pdd or other causes of dementia
Beskrivning

Epilepsy | Neurodegenerative Disorders | Exception Dementia due to Parkinson's disease | Exception Causes Dementia

Datatyp

boolean

Alias
UMLS CUI [1]
C0014544
UMLS CUI [2]
C0524851
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0236960
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0015127
UMLS CUI [4,3]
C0497327
any behavioral or physical problem that would preclude completion of the primary evaluation or treatment with cpap.
Beskrivning

Behavioral problem Excludes Evaluation | Physical illness Excludes Evaluation | Behavioral problem Excludes CPAP | Physical illness Excludes CPAP

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0233514
UMLS CUI [1,2]
C0332196
UMLS CUI [1,3]
C1261322
UMLS CUI [2,1]
C0683323
UMLS CUI [2,2]
C0332196
UMLS CUI [2,3]
C1261322
UMLS CUI [3,1]
C0233514
UMLS CUI [3,2]
C0332196
UMLS CUI [3,3]
C0199451
UMLS CUI [4,1]
C0683323
UMLS CUI [4,2]
C0332196
UMLS CUI [4,3]
C0199451
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Similar models

Eligibility Parkinson's Disease NCT00492115

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Dementia due to Parkinson's disease
Item
clinical diagnosis of dementia due to parkinson's disease (according to the fourth edition of the diagnostic and statistical manual of mental disorders (code 294.1)
boolean
C0236960 (UMLS CUI [1])
Mini-mental state examination | Cognitive symptoms
Item
mmse score between 18 and 26, inclusive; cognitive symptoms must occur at least one year after the diagnosis of pdd
boolean
C0451306 (UMLS CUI [1])
C0525041 (UMLS CUI [2])
Apnea-hypopnea index
Item
apnea hypopnea index >10 (i.e., 10 apneas plus hypopneas per hour of sleep)
boolean
C2111846 (UMLS CUI [1])
Age
Item
over the age of 50 years
boolean
C0001779 (UMLS CUI [1])
Health Stable
Item
stable health
boolean
C0018684 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Able to speak fluently English Language
Item
fluent english speaking
boolean
C0564241 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
Dopaminergic Agents | Acetylcholinesterase Inhibitors | Psychotropic Drugs | Nootropic Agents | Dietary Supplements | Pharmaceutical Preparations Dose Stable
Item
patients will be allowed to continue dopaminergic medications, acetylcholinesterase inhibitors, psychotropic medications, memory enhancers, health food supplements, etc. as long as they have been stable on the same dose for at least two months prior to participation and agree to continue on this dose for the duration of the 6-week study.
boolean
C0013036 (UMLS CUI [1])
C0001046 (UMLS CUI [2])
C0033978 (UMLS CUI [3])
C0242913 (UMLS CUI [4])
C0242295 (UMLS CUI [5])
C0013227 (UMLS CUI [6,1])
C0178602 (UMLS CUI [6,2])
C0205360 (UMLS CUI [6,3])
Item Group
C0680251 (UMLS CUI)
Therapeutic procedure Sleep Apnea
Item
current treatment for sleep apnea (to avoid discontinuing already established treatment for sleep apnea and any carry over confounding effect of treatment on cognition).
boolean
C0087111 (UMLS CUI [1,1])
C0037315 (UMLS CUI [1,2])
Sleep Apnea, Central
Item
central sleep apnea
boolean
C0520680 (UMLS CUI [1])
Pharmaceutical Preparations Affecting Sleep | Sedative hypnotics | Narcotics
Item
use of medications known to influence sleep (i.e. sedative hypnotics, narcotics) if the dose cannot remain stable for the duration of the study.
boolean
C0013227 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0037313 (UMLS CUI [1,3])
C0020592 (UMLS CUI [2])
C0027415 (UMLS CUI [3])
Chronic Obstructive Airway Disease Bronchial Spasm | Chronic Obstructive Airway Disease Symptomatic | Bronchodilator Agents Regular | Steroids | Hypercapnia | Hypoxemia Waking | PaO2 Pulse Oximetry | SpO2 Pulse Oximetry | Receiving supplemental oxygen
Item
bronchospastic and symptomatic chronic obstructive pulmonary disease as indicated by regular use of bronchodilators, steroids, history of carbon dioxide retention, waking hypoxemia (pao2 <60 mmhg or spo2 <92 % by pulse oximetry), or use of supplemental oxygen.
boolean
C0024117 (UMLS CUI [1,1])
C0006266 (UMLS CUI [1,2])
C0024117 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0006280 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
C0038317 (UMLS CUI [4])
C0020440 (UMLS CUI [5])
C0700292 (UMLS CUI [6,1])
C0442696 (UMLS CUI [6,2])
C1822073 (UMLS CUI [7,1])
C0034108 (UMLS CUI [7,2])
C2317096 (UMLS CUI [8,1])
C0034108 (UMLS CUI [8,2])
C3841316 (UMLS CUI [9])
Cardiovascular Diseases Symptomatic | Cerebrovascular Disorders Symptomatic | Myocardial Infarction | Angina Pectoris | Cerebrovascular accident | Transient Ischemic Attack | Cardiac Arrhythmia Life Threatening | Cardiomyopathy | Substance Use Disorders
Item
symptomatic coronary or cerebral vascular disease (history of myocardial infarction, angina, stroke, or transient ischemic attacks), history of life-threatening arrhythmias, cardiomyopathy, or current alcohol or drug abuse
boolean
C0007222 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0007820 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0002962 (UMLS CUI [4])
C0038454 (UMLS CUI [5])
C0007787 (UMLS CUI [6])
C0003811 (UMLS CUI [7,1])
C2826244 (UMLS CUI [7,2])
C0878544 (UMLS CUI [8])
C0038586 (UMLS CUI [9])
Epilepsy | Neurodegenerative Disorders | Exception Dementia due to Parkinson's disease | Exception Causes Dementia
Item
current diagnosis of active seizure disorder; presence of any neurodegenerative disorder other than pdd or other causes of dementia
boolean
C0014544 (UMLS CUI [1])
C0524851 (UMLS CUI [2])
C1705847 (UMLS CUI [3,1])
C0236960 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0015127 (UMLS CUI [4,2])
C0497327 (UMLS CUI [4,3])
Behavioral problem Excludes Evaluation | Physical illness Excludes Evaluation | Behavioral problem Excludes CPAP | Physical illness Excludes CPAP
Item
any behavioral or physical problem that would preclude completion of the primary evaluation or treatment with cpap.
boolean
C0233514 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0683323 (UMLS CUI [2,1])
C0332196 (UMLS CUI [2,2])
C1261322 (UMLS CUI [2,3])
C0233514 (UMLS CUI [3,1])
C0332196 (UMLS CUI [3,2])
C0199451 (UMLS CUI [3,3])
C0683323 (UMLS CUI [4,1])
C0332196 (UMLS CUI [4,2])
C0199451 (UMLS CUI [4,3])
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