Clinical trial NCT04996953: The Correlation Study of Hypnotic Drugs on the Cognitive Function of Patients With Chronic Insomnia.
Official title: The Correlation Study of Hypnotic Drugs on the Cognitive Function of Patients With Chronic Insomnia.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Insomnia Chronic
Keywords: Insomnia
Cognitive disorder
Hypnotic
Memory
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
First posted: 2021-08-09
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects were patients in the outpatient department of Qianfoshan Hospital in Shandong Province from August 2019 to June 2025. All patients met the diagnostic criteria for chronic insomnia.

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.

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.

Primary outcomes:
measure: Pittsburgh sleep quality index scale
timeFrame: 1 day
measure: Epworth Sleeping Scale
timeFrame: 1 day
measure: Insomnia Severity Index
timeFrame: 1 day
measure: Hamilton Anxiety Scale
timeFrame: 1 day
measure: Hamilton Depression Scale
timeFrame: 1 day
measure: The Word Learning Scale
timeFrame: 1 day
measure: The verbal Fluency Scale
timeFrame: 1 day
measure: The Numeral-Sign Conversion Test Scale
timeFrame: 1 day
measure: Digital Span Test Scale
timeFrame: 1 day
measure: Stroop Color Word Test Scale
timeFrame: 1 day
measure: Trail Making Test A and B Scale
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: The First Affiliated Hospital of Shandong First Medical University
state: Shandong
Study officials:
References: