Changed Serum Levels of Sirtuin1 and Sirtuin3 and Their Correlations With Sleep Quality and Cognitive Function in the Patients With Chronic Insomnia Disorder (SIRT1 SIRT3)

April 24, 2025 updated by: GaoXia Liu, Chaohu Hospital of Anhui Medical University

The goal of this study is to explore whether mitochondrial dysfunction exists in patients with chronic insomnia disorder. The main questions it aims to answer are :

  • Do serum mitochondrial markers change in patients with chronic insomnia?
  • Is there a relationship between serum mitochondrial markers and sleep and cognition in patients with chronic insomnia disorder? The researchers will compare serum mitochondrial marker levels among participants in the chronic insomnia group with those in the healthy group, and analyze the relationship between the markers and sleep and cognition of the participants.

Participants will:

  • Complete polysomnography, the Pittsburgh Sleep Quality Index (PSQI), the Chinese-BeiJing version of the Montreal cognitive assessment (MoCA-C), the Blue Velvet Arena Test (BVAT), the Nine Box Maze Test (NBMT) to assess sleep and cognition.
  • The venous blood was drawn to detect mitochondrial marker levels.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • An-Hui
      • Hefei, An-Hui, China, 238000
        • The Affiliated Chaohu Hospital of Anhui Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Qualified and voluntary subjects were recruited from the Sleep Disorder Department of Chaohu Hospital affiliated to Anhui Medical University from October 2021 to July 2023.

Description

Inclusion Criteria:

  • meet the diagnostic criteria of the third edition of the International Classification of Sleep Disorders,26 At the same time, meet the following requirements: ① Duration suffered form insomnia > 6 months; ② 18-60 years old; ③ Receiving education ≥ 9 years of, without any understanding and hearing impairment; ④ The Pittsburgh Sleep Quality Index (PSQI) > 7 sores, Hamilton Anxiety Scale-14 (HAMA-14) < 14 scores, The Patient Health Questionnaire-9 (PHQ-9) < 10 scores; ⑤ There was no history of any sedative and hypnotic drugs in the two weeks prior to the visit

Exclusion Criteria:

  • patients during pregnancy or breastfeeding or patients who have taken sedative hypnotic drugs or any other drugs that may affect sleep, mood and cognitive function within two weeks were not eligible for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The biological contents of SIRT1 and SIRT3 in all serum specimens were detected by enzyme-linked immunosorbent assay (ELISA)
Time Frame: Participants completed the assessment and PSG on the first day, and venous blood samples were collected at around 8 am on the next day for SIRT1 and SIRT3 detection
All the test data were analyzed by SPSS26.0 statistical software, When P≤ 0.05 was considered statistically significant, two-sided test was conducted. Compared with the healthy group, the levels of SIRT1 (Z= -6.718,P<0.001) and SIRT3 (Z=-6.223,P<0.001) in the CID group were significantly increased.
Participants completed the assessment and PSG on the first day, and venous blood samples were collected at around 8 am on the next day for SIRT1 and SIRT3 detection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chaohu Hospital of Anhui Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 2, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 81671316

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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