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

NCT06955299 | Completed

• 1 other identifier: 81671316
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Insomnia Disorder

Outcome Measures

Primary Outcomes (1)

• The biological contents of SIRT1 and SIRT3 in all serum specimens were detected by enzyme-linked immunosorbent assay (ELISA)

  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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chaohu Hospital of Anhui Medical University: lead

Study Sites (1)

The Affiliated Chaohu Hospital of Anhui Medical University

Hefei, Anhui, 238000, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master Degree Candidate

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: May 2, 2025
• Study Start: January 1, 2022
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: May 2, 2025

Record last verified: 2024-01

Locations

CN (1)