Cerebral Hemodynamics in Sleep Disorders

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

Study Overview

• Status: Completed
• Conditions: Sleep Disorders, Intrinsic

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.

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China, 130000
      • First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
patients with sleep disorders
normal individuals without sleep disorders

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
phase difference(PD) in degree	A dynamic cerebral auto-regulation parameter derived from transfer function analysis.Continuous cerebral blood flow velocities of bilateral middle cerebral artery will be assessed noninvasively using transcranial Doppler. Spontaneous arterial blood pressure will be simultaneously recorded using a servo-controlled plethysmograph on the left or right middle finger with an appropriate finger cuff size. Transfer function analysis will be used to derive the autoregulatory parameters.	6 months
the rate of recovery of cerebral blood flow velocity	A dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as outcome 1	6 months
gain in cm/s/mmHg	A dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as outcome 1	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
mean MCA blood flow velocity (mCBFV) changes from supine to upright position	6 months
pulsatility index (PI) changes from supine to upright position	6 months
resistance index (RI) changes from supine to upright position	6 months

Other Outcome Measures

Outcome Measure	Time Frame
scores of Pittsburgh sleep quality index(PSQI)	6 months
scores of Hamilton Anxiety Scale(HAMA)	6 months
scores of Hamilton Depression Scale(HAMD)	6 months
Polysomnography（PSG）	within 6 months

Collaborators and Investigators

• Sponsor: Yi Yang

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): October 26, 2018

Study Registration Dates

• First Submitted: March 7, 2016
• First Submitted That Met QC Criteria: April 22, 2016
• First Posted (Estimate): April 26, 2016

Study Record Updates

• Last Update Posted (Actual): November 27, 2018
• Last Update Submitted That Met QC Criteria: November 26, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: Stroke; Sleep Disorders; Cerebral Hemodynamics; Dynamic Cerebral Auto-Regulation
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Dyssomnias; Neurologic Manifestations; Disease; Sleep Wake Disorders; Parasomnias; Sleep Disorders, Intrinsic
• Other Study ID Numbers: CHSD-01-R

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No