Clinical trial NCT02752139: Cerebral Hemodynamics in Sleep Disorders
Official title: Cerebral Hemodynamics in Sleep Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorders, Intrinsic
Keywords: Sleep Disorders
Cerebral Hemodynamics
Dynamic Cerebral Auto-Regulation
Stroke
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2016-04-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators conducted a prospective study of consecutive patients with sleep disorders treated at the Department of Neurology, First Hospital of Jilin University, China, from March 2016 to March 2017. Each patient was diagnosed with intrinsic sleep disorders by two neurologists according to the Diagnostic Criteria for Sleep Dyssomnias.

Brief summary: The purpose of this study is to determine the relationship between sleep disorders and cerebral hemodynamics.

Detailed description: Sleep disorders continue to be the most unrecognized modifiable risk factor for stroke. The relationship between sleep disorders and vascular risk factors and stroke has been well-documented but not fully understood. The investigators hypothesize hemodynamics impairment to be its potential mechanism. It has been reported that sleep-related breathing disorder, a type of sleep disorders, contributed as a risk factor for stroke through hemodynamic and hematologic changes. The purpose of this study is to determine the relationship between different kind of sleep disorders and cerebral hemodynamics, including OSHAS, RLS, RBD, narcolepsy, etc. The dynamic cerebral auto-regulation (dCA) and Transcranial Doppler (TCD) will be used to evaluate cerebral hemodynamics.

Eligibility criteria: Inclusion Criteria:

* patients with sleep disorders
* meet the Diagnostic Criteria for Sleep Dyssomnias
* sufficient bilateral temporal bone windows for insonation of the MCA

Exclusion Criteria:

* middle cerebral artery (MCA) and/or other intracranial and/or extracranial major vascular 4 stenosis/occlusion, as diagnosed by a transcranial Doppler
* having a prior symptomatic cerebral vascular disease
* current arrhythmia, hyperthyroidism, anemia and unstable blood pressure, which may undermine hemodynamic stability
* inability to cooperate sufficiently to complete the dCA examination

Primary outcomes:
measure: phase difference(PD) in degree
timeFrame: 6 months
measure: the rate of recovery of cerebral blood flow velocity
timeFrame: 6 months
measure: gain in cm/s/mmHg
timeFrame: 6 months
Secondary outcomes:
measure: mean MCA blood flow velocity (mCBFV) changes from supine to upright position
timeFrame: 6 months
measure: pulsatility index (PI) changes from supine to upright position
timeFrame: 6 months
measure: resistance index (RI) changes from supine to upright position
timeFrame: 6 months
Other outcomes:
measure: scores of Pittsburgh sleep quality index(PSQI)
timeFrame: 6 months
measure: scores of Hamilton Anxiety Scale(HAMA)
timeFrame: 6 months
measure: scores of Hamilton Depression Scale(HAMD)
timeFrame: 6 months
measure: Polysomnography（PSG）
timeFrame: within 6 months
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
References:
citation: Deng F, Zhang Y, Zhang R, Tang Q, Guo Z, Lv Y, Wang Z, Yang Y. Compromised Dynamic Cerebral Autoregulation in Patients With Central Disorders of Hypersomnolence. Front Neurol. 2021 Mar 11;12:634660. doi: 10.3389/fneur.2021.634660. eCollection 2021.