Skip to main content
OpenTrials
Completed

NCT Number: NCT02752139

Cerebral Hemodynamics in Sleep Disorders

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sleep Disorders, Intrinsic Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

First Hospital of Jilin University

Changchun, Jilin, 130000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. phase difference(PD) in degree

    Time frame: 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.

  2. the rate of recovery of cerebral blood flow velocity

    Time frame: 6 months

    A dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as outcome 1

  3. gain in cm/s/mmHg

    Time frame: 6 months

    A dynamic cerebral auto-regulation parameter derived from transfer function analysis.The details are same as outcome 1

Secondary outcomes

  1. mean MCA blood flow velocity (mCBFV) changes from supine to upright position

    Time frame: 6 months

  2. pulsatility index (PI) changes from supine to upright position

    Time frame: 6 months

  3. resistance index (RI) changes from supine to upright position

    Time frame: 6 months

Other outcomes

  1. scores of Pittsburgh sleep quality index(PSQI)

    Time frame: 6 months

  2. scores of Hamilton Anxiety Scale(HAMA)

    Time frame: 6 months

  3. scores of Hamilton Depression Scale(HAMD)

    Time frame: 6 months

  4. Polysomnography（PSG）

    Time frame: within 6 months

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Apr 26, 2016
Registry last updated
Nov 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.