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

Completed

Study Type

Observational

Enrollment (Actual)

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

    • 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

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

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.

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)

January 1, 2022

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

April 14, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

January 1, 2024

More Information

Terms related to this study

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.

Clinical Trials on Chronic Insomnia Disorder

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