Characteristics andAffecting Factors Amalysis of Sleep Disorder in Parkinsons Disease

• Register: ChiCTR
• Last refreshed on: 18 April 2017
• Main ID: ChiCTR-CPC-15007223
• Date of registration: 2015-09-22
• Prospective Registration: Yes
• Primary sponsor: Department of Neurology, Changzheng Hospital, Second Military Medical University
• Public title: Characteristics andAffecting Factors Amalysis of Sleep Disorder in Parkinsons Disease
• Scientific title: Characteristics andAffecting Factors Amalysis of Sleep Disorder in Parkinsons Disease
• Date of first enrolment: 2016-01-01
• Target sample size: The treatment group; The control group:100;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=11982
• Study type: Cause
• Study design: Cohort study
• Phase: Post-market

Countries of recruitment

China

Contacts

• Name: Wang Yan

• Name: Wang Yan
• Affiliation: Department of Neurology, Changzheng Hospital, Second Military Medical University

Key inclusion & exclusion criteria

Inclusion criteria: (1) the subjects or his legal representative signed by an independent ethics committee (IEC) approved by the written informed consent form and indicate the date;
(2) according to the researcher's judgment that the subjects/legal representative is trustworthy, and able to abide by the scheme, supervision program and applied study drugs;
(3) the participants with idiopathic Parkinson's disease, its diagnosis according to the main symptoms of slow motion, coupled with the following symptoms: at least one static tremor, rigidity, or posture reflex is damaged, and no other known or suspected etiology of Parkinson's disease;
(4) the subjects' Hoehn and Yahr stage 1 to 5;
(5) first visit the participants in the screening for the age of 30 or more male or female;
(6) first visit the participants in the screening of MMSE score 25 or more;
(7) Baseline (supervision) when the subjects' UPDRS motor score (part III) 10 or higher;
(8) if the symptoms of the subjects accept anticholinergic drugs (for example, benzalkonium tropic, benzene hai suo, diethyl promethazine, its organism and than pp board), monoamine oxidase (MAO) - B B inhibitors (for example, a department to gillan), N - methyl - d - aspartate (NMDA) antagonist (such as amantadine) treatment, then he/she must accept before baseline visit at least 28 days, stable doses and maintain the dose treatment during the study period.
Exclusion criteria: (1) the subjects previously participated in this study or previously received study medication in this study;
(2) the subjects are engaged in another study of experimental drugs or in baseline visits within 28 days before the visit involved in such studies;
(3) or other subjects have serious adhesives transdermal preparations of skin allergy or recent contact dermatitis and has not been cured;
(4) the subjects had a history of suicide attempts, including active attempt to try, try to be interrupted or failed), or in the past six months have suicidal ideation, through the screening period finished visit, Columbia, suicidal severity scale (C - SSRS) answer question 4 or 5 for sure;
(5) were due to the use of drugs (for example, methoxychlor amine,Inherited metabolic disease of nervous system (for example, Wilson's disease), encephalitis, cerebrovascular disease, or degenerative disease (for example, a progressive paralysis on nuclear) caused by the atypical symptoms of Parkinson's disease;
(6) of the subjects had globus pallidus dissection, thalamotomy, deep brain stimulation or embryonic tissue transplantation;
(7) the subjects suffering from dementia, active mental illness or hallucinations or major depression;
(8) of the subjects were treated with dopamine agonists, or at the same time in the baseline visit within 28 days before the visit to accept such treatment;
(9) subjects at the same time or before baseline visit accepted within 28 days following a drug treatment: alpha methyldopa, methoxychlor amine, reserpine, antipsychotics (except for certain atypical antipsychotics: olanzapine, ziprasidoneMAO - A inhibitor, methylphenidate or amphetamines;
(10) of the subjects are positive nervous system (CNS) disease treatment (for example, sedatives and sleeping pills and antidepressants, antianxiety drugs), unless prior to baseline visit at least 28 days dose remained stable, and can remain stable during the study period;
(11) the participants currently diagnosed with epilepsy, adult after the history of seizures, has a history of stroke or phase in the screening visit before 1 year appeared transient ischemic attack;
(12) subjects with clinical significance of hepatic insufficiency (defined as total bilirubin > 2.0 mg/dl or alanine aminotransferase (ALT) and/or aspertate aminotransferase (AST) 2 times higher than that of reference range limit);
(13) the subjects there is clinical significance;
(14) subjects with clinical significance of cardiac insufficiency (researchers think that may make the subjects faced with clinical significance of arrhythmia risk of heart disease) and/or myocardial infarction happened in the past 12 months;
(15) in screening visit, according to the Bazett formula between QT period after correction of heart rate (QTcB) or 500 ms;
(16) subjects have symptomatic (asymptomatic) history of orthostatic hypotension, before baseline visit from supine to upright positions, within 28 days after 1 or 3 minutes SBP drop 20 MMHG or DBP decreased acuity 10 MMHG or higher, or in research is SBP < 105 MMHG;
(17) in screening visit when the subjects had evidence of impulse control disorders (ICD);
(18) subjects had known allergic to the following antiemetic intolerance/s: more Pan Li ketone, three oxygen benzene amide, the Dan SiQiong, tropane SiQiong, gamla SiQiong and lung bromide.
(19) The subjects in the past five years has a long history of alcoholism or drug abuse;
(20) subjects for women during pregnancy

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Parkinsons Disease; Sleep Disorder

Intervention(s)

The treatment group; The control group:Rotigotine patch;

Primary Outcome(s)

polysomnography record;

Source(s) of Monetary Support

national natural science foundation project (81070070; 81171252)