The Correlation Study of Hypnotic Drugs on the Cognitive Function of Patients With Chronic Insomnia.

NCT ID: NCT04996953

Last Updated: 2021-08-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 165 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-06-01
• Study Completion Date: 2025-07-01

Brief Summary

All the subjects were assessed for sleep quality, anxiety and depression, and cognitive function. Based on their previous hypnotic medication history, they were divided into a non-medicine group and a benzodiazepine group，and the group taking non-benzodiazepine drugs.The cognitive effects of different hypnotic drugs on patients were evaluated by comparing sleep related scale and cognitive function scale.

Detailed Description

Insomnia is one of the most common sleep disorders, with 38.2% of Chinese people suffering from sleep disorders. There are many ways to treat insomnia disorders, but drug therapy is the most commonly used method by medical staff. The cognitive effects of sleep drugs vary in numerous studies, depending on the type and dosage of drugs.This study aims to explore the effects of different types of hypnotic drugs on the treatment of insomnia and cognitive function, hoping to improve the sleep quality and living standards of insomnia patients through this study, and also to obtain some cognitive impairment prevention measures related to insomnia, to provide some theoretical basis for clinical treatment.

Conditions

Insomnia Chronic

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

165 patients with insomnia

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Signed informed consent, male or female ≥18 and ≤75 years old;

2. (ICSD-3) proposed the diagnostic criteria for chronic insomnia;

2. Did not take hypnotic drugs before the visit; 3. Those who took hypnotic drugs before the visit; 4. Can understand and comply with the study protocol;

Exclusion Criteria

1. Severe organic disease;

2. Any suicidal behavior in the past 10 years;

3. Those who cannot communicate normally cannot cooperate to complete the scale test;

4. Women who are breastfeeding or pregnant;

5. Medical history that the investigator believes could affect the safety of the subject or interfere with the study evaluation;

6. Currently diagnosed with sleep apnea, narcolepsy and other sleep disorders;

7. Sleep disorders caused by central nervous system diseases, or neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, lewy bodies dementia.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lili Cao

OTHER

Sponsor Role: lead

Responsible Party

Lili Cao

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

The First Affiliated Hospital of Shandong First Medical University

Jinan, Shandong, China

Countries

China

Other Identifiers

KUN0802

Identifier Type: -

Identifier Source: org_study_id