Neurodegenerative DisorderNCT05524922
A Registered Cohort Study on Neurodegenerative Associated With Sleep Disorder.
An observational study of Neurodegenerative Disorder, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
Cognitive impairment often appears in neurodegenerative diseases, and it is expected to further study the mechanism of sleep disorders associated with the progression of neurodegenerative diseases by exploring the clinical manifestations, imaging, and biological marker changes of sleep disorders in neurodegenerative… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Neurodegenerative Disorder
- What is being tested?
- Data collection
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2021to 1 Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 80 years
- All sexes
- Adult, Older adult
Study population: Neurodegenerative disorders are a cluster of chronic progressive diseases characterized by specific pathological manifestations. Common neurodegenerative disorders include Alzheimer's disease, Parkinson's disease and so on. We studied people with sleep disorders associated with neurodegenerative disorders.
Who may be able to join
- clinical diagnosis of neurodegenerative disease.
- patients experience insomnia, excessive drowsiness, or confusion at night.
- Patients experience frequent awakenings, daily sleep episodes, or nocturnal confusion.
- The presence of one or more of the following characteristics: a. wandering at night with inappropriate activity; b. agitation, combativeness; c. confusion, disorientation, or marked delirium.
- Polysomnographic monitoring showed the following two conditions: a. poor sleep efficiency, increased number and duration of awakenings; b. multiple sleep latency tests showed increased daytime sleepiness.
- Presence of other medical symptoms that do not indicate the primary disease.
- Other sleep disorders (e.g., periodic limb movement disorders, obstructive sleep apnea syndrome) may be present, but do not explain the patient 's main symptoms.
- any of the above can be diagnosed
Who cannot join
- Patients with other neurological disorders.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Xiaodong Pan, 0591-86218341, pxd77316@163.com
About this study
Official title: A Registered Observational Cohort Study on Neurodegenerative Associated With Sleep Disorder.
Cognitive impairment often appears in neurodegenerative diseases, and it is expected to further study the mechanism of sleep disorders associated with the progression of neurodegenerative diseases by exploring the clinical manifestations, imaging, and biological marker changes of sleep disorders in neurodegenerative diseases.
- Conditions
- Neurodegenerative Disorder
- Being tested
- Data collection
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Neuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected
| Study group | Role | What they receive |
|---|---|---|
| Neurodegenerative disorders associated with sleep disorders | Not described Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSQI Scores
Pittsburgh Sleep Quality Index (PSQI),
Measured: Baseline
Secondary outcomes (7)
MoCA scores
The Montreal Cognitive Assessment (MoCA)
Measured: Baseline
ACE-III scores
Addenbrooke's Cognitive Examination (ACE) score
Measured: Baseline
HRV (ms)
Heart rate variability (HRV) was calculated as the maximum bpm - minimum bpm.
Measured: Baseline
Plasma Aβ-42 levels (ng/ml)
Measured: Baseline
Vic
The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.
Measured: Baseline
PAF (Hz)
The alpha-peak frequency (PAF) is the frequency with the highest power within the alpha-band.
Measured: Baseline
Vic
The intra-cellular compartment (Vic) of the Neurite Orientation Dispersion and Density Imaging (NODDI) model represents diffusion within the axons and cells.
Measured: 1 year after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start1 Sep 2021
- Primary completion1 Jun 2030 (estimated)
- Study completion1 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DisorderStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524922
- Sponsor's protocol ID
- Cohort-Sleep Disorder
- Status last verified
- Sep 2024
- First submitted
- 28 Aug 2022
- Last updated
- 22 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registered Observational Cohort Study on Neurodegenerative Associated With Sleep Disorder.
- ClinicalTrials.gov ID
- NCT05524922
- Acronym / sponsor ID
- Cohort-Sleep Disorder
- Conditions
- Neurodegenerative Disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Jun 2030 (estimated)
- Study completion
- 1 Jun 2030 (estimated)
- First posted
- 1 Sep 2022 (actual)
- 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.
Cognitive impairment often appears in neurodegenerative diseases, and it is expected to further study the mechanism of sleep disorders associated with the progression of neurodegenerative diseases by exploring the clinical manifestations, imaging, and biological marker changes of sleep disorders in neurodegenerative diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurodegenerative disorders associated with sleep disorders | – | Other: Data collection |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Neurodegenerative disorders are a cluster of chronic progressive diseases characterized by specific pathological manifestations. Common neurodegenerative disorders include Alzheimer's disease, Parkinson's disease and so on. We studied people with sleep disorders associated with neurodegenerative disorders.
Key inclusion criteria (8 listed)
- clinical diagnosis of neurodegenerative disease.
- patients experience insomnia, excessive drowsiness, or confusion at night.
- Patients experience frequent awakenings, daily sleep episodes, or nocturnal confusion.
- The presence of one or more of the following characteristics: a. wandering at night with inappropriate activity; b. agitation, combativeness; c. confusion, disorientation, or marked delirium.
- Polysomnographic monitoring showed the following two conditions: a. poor sleep efficiency, increased number and duration of awakenings; b. multiple sleep latency tests showed increased daytime sleepiness.
Key exclusion criteria (2 listed)
- Patients with other neurological disorders.
- Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectionNeuropsychological assessment, brain MRI, electroencephalogram and biomarker datas will be collected | Other | Neurodegenerative disorders associated with sleep disorders |
Primary outcome
PSQI Scores
Time frame: Baseline
Pittsburgh Sleep Quality Index (PSQI),
7 secondary outcomes
MoCA scores
Time frame: Baseline
ACE-III scores
Time frame: Baseline
HRV (ms)
Time frame: Baseline
Plasma Aβ-42 levels (ng/ml)
Time frame: Baseline
Vic
Time frame: Baseline
PAF (Hz)
Time frame: Baseline
Vic
Time frame: 1 year after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Individual participant dataSharing planned: No
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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.
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 Neurodegenerative Disorder, run by Fujian Medical University Union Hospital 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 8 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaodong Pan, Doctor (0591-86218341, pxd77316@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PSQI Scores (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jan 2025.