Cerebral Hemodynamics in Sleep Disorders

Sponsor

Yi Yang (Other)

Overall Status

Completed

CT.gov ID

NCT02752139

Collaborator

(none)

300

Enrollment

Location

29.8

Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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 Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

300 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Cerebral Hemodynamics in Sleep Disorders

Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Aug 1, 2018

Actual Study Completion Date :

Oct 26, 2018

Arms and Interventions

Arm	Intervention/Treatment
patients with sleep disorders
normal individuals without sleep disorders

Outcome Measures

Primary Outcome Measures

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

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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