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Cerebral Hemodynamics in Sleep Disorders

Cerebral Hemodynamics in Sleep Disorders

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02752139
Enrollment
300
Registered
2016-04-26
Start date
2016-05-31
Completion date
2018-10-26
Last updated
2018-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Disorders, Intrinsic

Keywords

Sleep Disorders, Cerebral Hemodynamics, Dynamic Cerebral Auto-Regulation, Stroke

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.

Interventions

None listed

Sponsors

Yi Yang
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frameDescription
phase difference(PD) in degree6 monthsA 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.
gain in cm/s/mmHg6 monthsA dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as outcome 1
the rate of recovery of cerebral blood flow velocity6 monthsA dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as outcome 1

Secondary

MeasureTime frame
pulsatility index (PI) changes from supine to upright position6 months
mean MCA blood flow velocity (mCBFV) changes from supine to upright position6 months
resistance index (RI) changes from supine to upright position6 months

Other

MeasureTime frame
scores of Hamilton Anxiety Scale(HAMA)6 months
Polysomnography(PSG)within 6 months
scores of Hamilton Depression Scale(HAMD)6 months
scores of Pittsburgh sleep quality index(PSQI)6 months

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026