- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06955299
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
Conditions
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
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Chronic Insomnia Disorder
-
University of PennsylvaniaPatient-Centered Outcomes Research InstituteRecruitingInsomnia | Chronic Insomnia | Insomnia Disorder | Chronic Insomnia DisorderUnited States
-
San Francisco Neurology and Sleep CenterNot yet recruitingInsomnia | Sleep Disturbance | Chronic Insomnia | Chronic Insomnia DisorderUnited States
-
Christoph NissenRecruitingInsomnia | Insomnia Chronic | Insomnia Disorder | Insomnia, Primary | Insomnia Type; Sleep Disorder | Insomnia Disorders | Insomnia, NonorganicSwitzerland
-
University Hospital, BordeauxRecruitingCircadian Rhythm Disorders | Chronic Insomnia DisorderFrance
-
Diakonhjemmet HospitalCompletedSleep Disorder | Insomnia | Sleep Initiation and Maintenance Disorders | Sleep Disturbance | Mental Illness | Depression, Anxiety | Insomnia Chronic | Psychological Disorder | Insomnia Due to Mental Disorder | Insomnia, PsychophysiologicalNorway
-
Federal University of Minas GeraisHarvard Medical School (HMS and HSDM)Active, not recruitingDepressive Disorder | Quality of Life | Sleep Disorder | Anxiety Disorders | Insomnia | Spirituality | Stress Disorder | Insomnia Chronic | Insomnia Disorder | Complementary TherapyBrazil
-
Qinying MaRecruitingChronic Insomnia DisorderChina
-
Central South UniversityThe Third Hospital of Inner Mongolia Autonomous RegionCompletedChronic Insomnia DisorderChina
-
WELT corpNot yet recruiting
-
Chinese University of Hong KongNot yet recruiting