NCT02752139

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 26, 2016

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 26, 2018

Completed
Last Updated

November 27, 2018

Status Verified

November 1, 2018

Enrollment Period

2.3 years

First QC Date

March 7, 2016

Last Update Submit

November 26, 2018

Conditions

Sleep Disorders, Intrinsic

Keywords

Sleep DisordersCerebral HemodynamicsDynamic Cerebral Auto-RegulationStroke

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (3)

  • 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 Outcomes (4)

  • 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

  • +1 more other outcomes

Study Arms (2)

patients with sleep disorders

normal individuals without sleep disorders

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The investigators conducted a prospective study of consecutive patients with sleep disorders treated at the Department of Neurology, First Hospital of Jilin University, China, from March 2016 to March 2017. Each patient was diagnosed with intrinsic sleep disorders by two neurologists according to the Diagnostic Criteria for Sleep Dyssomnias.

You may qualify if:

  • patients with sleep disorders
  • meet the Diagnostic Criteria for Sleep Dyssomnias
  • sufficient bilateral temporal bone windows for insonation of the MCA

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Related Publications (1)

  • Deng F, Zhang Y, Zhang R, Tang Q, Guo Z, Lv Y, Wang Z, Yang Y. Compromised Dynamic Cerebral Autoregulation in Patients With Central Disorders of Hypersomnolence. Front Neurol. 2021 Mar 11;12:634660. doi: 10.3389/fneur.2021.634660. eCollection 2021.

    PMID: 33776891DERIVED

MeSH Terms

Conditions

Sleep Disorders, IntrinsicSleep Wake DisordersStroke

Condition Hierarchy (Ancestors)

DyssomniasNervous System DiseasesMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associated Dean of First Hospital of Jilin University

Study Record Dates

First Submitted

March 7, 2016

First Posted

April 26, 2016

Study Start

May 1, 2016

Primary Completion

August 1, 2018

Study Completion

October 26, 2018

Last Updated

November 27, 2018

Record last verified: 2018-11

Locations

CN(1)