Cerebral Hemodynamics in Sleep Disorders

Completed

• Conditions: Sleep Disorders, Intrinsic

• Registration Number: NCT02752139
• Lead Sponsor: Yi Yang

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.

Study Timeline

• Study First Submitted: 2016-03-07
• Study First Submitted QC: 2016-04-22
• Study First Posted: 2016-04-26
• Study Start: 2016-05
• Primary Completion: 2018-08
• Study Completion: 2018-10-26
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-26
• Last Update Posted: 2018-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
phase difference(PD) in degree	6 months	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.
the rate of recovery of cerebral blood flow velocity	6 months	A dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as outcome 1
gain in cm/s/mmHg	6 months	A dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as outcome 1

Secondary Outcome Measures

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

Trial Locations

Locations (1)

First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China