Sleep Disorders, IntrinsicNCT02752139
Cerebral Hemodynamics in Sleep Disorders
An observational study of Sleep Disorders, Intrinsic, run by Yi Yang at 1 site in China.
Trial summary
The purpose of this study is to determine the relationship between sleep disorders and cerebral hemodynamics. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep Disorders, Intrinsic
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- May 2016to 26 Oct 2018
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- patients with sleep disorders
- meet the Diagnostic Criteria for Sleep Dyssomnias
- sufficient bilateral temporal bone windows for insonation of the MCA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the relationship between sleep disorders and cerebral hemodynamics.
Read the 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.
- Conditions
- Sleep Disorders, Intrinsic
- Keywords
- Sleep Disorders, Cerebral Hemodynamics, Dynamic Cerebral Auto-Regulation, Stroke
- Medical subject headings
- Sleep Disorders, Intrinsic, Sleep Wake Disorders, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with sleep disorders | Not described | |
| normal individuals without sleep disorders | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: 6 months
Secondary outcomes (3)
mean MCA blood flow velocity (mCBFV) changes from supine to upright position
Measured: 6 months
pulsatility index (PI) changes from supine to upright position
Measured: 6 months
resistance index (RI) changes from supine to upright position
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionAug 2018
- Study completion26 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sleep Disorders, IntrinsicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752139
- Sponsor's protocol ID
- CHSD-01-R
- Status last verified
- Nov 2018
- First submitted
- 7 Mar 2016
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhang Y, Piao Y, Sun Q, Li H, Wang Y, Lu J, Guo Z, Wang Z. Impaired Dynamic Cerebral Autoregulation Across the REM Sleep Behavior Disorder Spectrum: Evidence From Isolated REM Sleep Without Atonia to Parkinson's Disease With RBD. CNS Neurosci Ther. 2026 Oct;32(10):e71190. doi: 10.1002/cns.71190.
PubMed 42905881Deng 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.
PubMed 33776891
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Hemodynamics in Sleep Disorders
- ClinicalTrials.gov ID
- NCT02752139
- Acronym / sponsor ID
- CHSD-01-R
- Conditions
- Sleep Disorders, Intrinsic
- Keywords
- Sleep Disorders, Cerebral Hemodynamics, Dynamic Cerebral Auto-Regulation, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- 26 Oct 2018 (actual)
- First posted
- 26 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with sleep disorders | – | – |
| normal individuals without sleep disorders | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- patients with sleep disorders
- meet the Diagnostic Criteria for Sleep Dyssomnias
- sufficient bilateral temporal bone windows for insonation of the MCA
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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
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
3 secondary outcomes
mean MCA blood flow velocity (mCBFV) changes from supine to upright position
Time frame: 6 months
pulsatility index (PI) changes from supine to upright position
Time frame: 6 months
resistance index (RI) changes from supine to upright position
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2018.
- Derived from this study: PubMed 42905881Zhang Y, Piao Y, Sun Q, Li H, Wang Y, Lu J, Guo Z, Wang Z. Impaired Dynamic Cerebral Autoregulation Across the REM Sleep Behavior Disorder Spectrum: Evidence From Isolated REM Sleep Without Atonia to Parkinson's Disease With RBD. CNS Neurosci Ther. 2026 Oct;32(10):e71190. doi: 10.1002/cns.71190.
- Derived from this study: PubMed 33776891Deng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Disorders, Intrinsic, run by Yi Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
phase difference(PD) in degree (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02752139, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2018.