Cerebral Hemodynamics in Sleep Disorders

Sleep Disorders, Intrinsic Clinical Trial

Official title:

Cerebral Hemodynamics in Sleep Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02752139
• Other study ID #: CHSD-01-R
• Status: Completed
• Start date: May 2016
• Est. completion date: October 26, 2018

Study information

• Verified date: November 2018
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 26, 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Parasomnias
• Sleep Disorders, Intrinsic
• Sleep Wake Disorders

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	scores of Pittsburgh sleep quality index(PSQI)		6 months
Other	scores of Hamilton Anxiety Scale(HAMA)		6 months
Other	scores of Hamilton Depression Scale(HAMD)		6 months
Other	Polysomnography(PSG)		within 6 months
Primary	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
Primary	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
Primary	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	mean MCA blood flow velocity (mCBFV) changes from supine to upright position		6 months
Secondary	pulsatility index (PI) changes from supine to upright position		6 months
Secondary	resistance index (RI) changes from supine to upright position		6 months