Insomnia ChronicNCT04996953

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

An observational study of Insomnia Chronic, run by Lili Cao at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial 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… Read more about this study

Who is it for?: Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for: Insomnia Chronic
How many people: 165 participants
Where: 1 siteChina
Study dates: 1 Jun 2021to 1 Jul 2025
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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.

Who may be able to join

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

Who cannot join

Severe organic disease;
Any suicidal behavior in the past 10 years;
Those who cannot communicate normally cannot cooperate to complete the scale test;
Women who are breastfeeding or pregnant;
Medical history that the investigator believes could affect the safety of the subject or interfere with the study evaluation;
Currently diagnosed with sleep apnea, narcolepsy and other sleep disorders;
Sleep disorders caused by central nervous system diseases, or neurodegenerative diseases such as Parkinson's disease, Alzheimer's disease, lewy bodies dementia.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong

Other trials in China

About this study

Read the 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
Keywords: Insomnia, Cognitive disorder, Hypnotic, Memory
Medical subject headings: Sleep Initiation and Maintenance Disorders, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04996953
Study group	Role	What they receive
165 patients with insomnia		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

Pittsburgh sleep quality index scale
The sleep quality of the patients in the past month was evaluated. The higher the score, the worse the sleep quality. The scale of the score is 0-21, and the higher score means a worse outcome.
Measured: 1 day
Epworth Sleeping Scale
Assess the possibility of dozing (not just feeling tired) in recent months. The higher the score was, the more likely it was to doze during the day. The scale of the score is 0-24, and the higher score means a worse outcome.
Measured: 1 day
Insomnia Severity Index
Liker scale is used to evaluate the nature and symptoms of sleep disorders. The higher the score, the more serious the insomnia. The scale of the score is 0-28, and the higher score means a worse outcome.
Measured: 1 day
Hamilton Anxiety Scale
It can be used to evaluate the depressive symptoms of depression, manic depression, neurosis and other diseases. The scale of the score is 0-56, and the higher score means a worse outcome.
Measured: 1 day
Hamilton Depression Scale
It can be used to evaluate the depressive symptoms of depression, manic depression, neurosis and other diseases. The higher the score, the more severe the depression. The scale of the score is 0-96, and the higher score means a worse outcome.
Measured: 1 day
The Word Learning Scale
used to evaluate the subjects from two aspects of immediate recall and long-term delayed recall. The evaluation content included 15 words in five categories: body parts, animals, tools, vehicles and furniture. The 15 words were first presented three times.The score of immediate recall was the total number of words recalled three times, and the score of short-term delay recall was the correct number of free recall after 2min.Among them, immediate memory lower than 18 indicates that immediate memory function is impaired, and delayed memory lower than 6 indicates that delayed memory is impaired.the higher scores mean a better outcome.
Measured: 1 day
The verbal Fluency Scale
They were asked to name as many animals, fruits and vegetables as possible in a 60-second experiment,the higher scores mean a better outcome.
Measured: 1 day
The Numeral-Sign Conversion Test Scale
The tester placed the test in front of the subject, with a number above it and a symbol below it, with a different symbol for each number.Subjects were given 90 seconds to fill each space with a symbol that matched the sample, and were given one point for each symbol that matched, the higher the score, the better.
Measured: 1 day
Digital Span Test Scale
To assess the subjects' attention span, forward and backward number spans were the subjects' ability to recite a series of numbers in the correct order.Participants were asked to repeat a series of random numbers in reverse order, reading each number for one second.Participants were asked to repeat the number in reverse order.Each set of numbers was randomly composed of the numbers 1 to 9, and the highest success score was calculated.The most successful scores were back-to-back 10 points and back-to-back 8 points.The higher the score, the better.
Measured: 1 day
Stroop Color Word Test Scale
The executive ability of the subjects was assessed by the number of questions correctly answered by the subjects within 1min, which was divided into three types of cards: A, B and C, and each card had 100 items.Subjects correctly read the total number of red, blue, and green color names printed in black on card A within 1min, correctly identify the total number of red, blue, and green color backgrounds on card B within 1min, and correctly read the total number of different colors with red, blue, and green names on card C within 1min.For all parts of the Stroop test, the result is the time required to complete the C-card task, and the correct number, which is a kind of executive function test.The longer it takes, the worse the result, the higher the correct number, the better.
Measured: 1 day
Trail Making Test A and B Scale
Test A: Show the numbers from 1 to 25. They are randomly distributed. Connect them in the order of 1, 2, 3, all the way to 25.Test B: There are numbers 1 to 13, black and white, respectively, in the order of the color black and white cameras, such as white 1 with black 1, black 1 with white 2, white 2 with black 2, all the way to 13.the higher scores mean a worse outcome.
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 20211 Jul 2025

First posted9 Aug 2021
Study start1 Jun 2021
Primary completion1 Jul 2024 (estimated)
Study completion1 Jul 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Insomnia ChronicStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Cross-sectional
Enrolment: 165 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04996953
Sponsor's protocol ID: KUN0802
Status last verified: Aug 2021
First submitted: 2 Aug 2021
Last updated: 16 Aug 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Insomnia Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Correlation Study of Hypnotic Drugs on the Cognitive Function of Patients With Chronic Insomnia.
ClinicalTrials.gov ID: NCT04996953
Acronym / sponsor ID: KUN0802
Conditions: Insomnia Chronic
Keywords: Insomnia, Cognitive disorder, Hypnotic, Memory
Study type: Observational
Recruitment status: Unknown status
Enrolment: 165 participants (estimated)
Lead sponsor: Lili CaoUniversity, hospital or other
Study start: 1 Jun 2021 (actual)
Primary completion: 1 Jul 2024 (estimated)
Study completion: 1 Jul 2025 (estimated)
First posted: 9 Aug 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case only
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
165 patients with insomnia	–	–

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

Severe organic disease;
Any suicidal behavior in the past 10 years;
Those who cannot communicate normally cannot cooperate to complete the scale test;
Women who are breastfeeding or pregnant;
Medical history that the investigator believes could affect the safety of the subject or interfere with the study evaluation;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Pittsburgh sleep quality index scale
Time frame: 1 day
The sleep quality of the patients in the past month was evaluated. The higher the score, the worse the sleep quality. The scale of the score is 0-21, and the higher score means a worse outcome.
Epworth Sleeping Scale
Time frame: 1 day
Assess the possibility of dozing (not just feeling tired) in recent months. The higher the score was, the more likely it was to doze during the day. The scale of the score is 0-24, and the higher score means a worse outcome.
Insomnia Severity Index
Time frame: 1 day
Liker scale is used to evaluate the nature and symptoms of sleep disorders. The higher the score, the more serious the insomnia. The scale of the score is 0-28, and the higher score means a worse outcome.
Hamilton Anxiety Scale
Time frame: 1 day
It can be used to evaluate the depressive symptoms of depression, manic depression, neurosis and other diseases. The scale of the score is 0-56, and the higher score means a worse outcome.
Hamilton Depression Scale
Time frame: 1 day
It can be used to evaluate the depressive symptoms of depression, manic depression, neurosis and other diseases. The higher the score, the more severe the depression. The scale of the score is 0-96, and the higher score means a worse outcome.
The Word Learning Scale
Time frame: 1 day
used to evaluate the subjects from two aspects of immediate recall and long-term delayed recall. The evaluation content included 15 words in five categories: body parts, animals, tools, vehicles and furniture. The 15 words were first presented three times.The score of immediate recall was the total number of words recalled three times, and the score of short-term delay recall was the correct number of free recall after 2min.Among them, immediate memory lower than 18 indicates that immediate memory function is impaired, and delayed memory lower than 6 indicates that delayed memory is impaired.the higher scores mean a better outcome.
The verbal Fluency Scale
Time frame: 1 day
They were asked to name as many animals, fruits and vegetables as possible in a 60-second experiment,the higher scores mean a better outcome.
The Numeral-Sign Conversion Test Scale
Time frame: 1 day
The tester placed the test in front of the subject, with a number above it and a symbol below it, with a different symbol for each number.Subjects were given 90 seconds to fill each space with a symbol that matched the sample, and were given one point for each symbol that matched, the higher the score, the better.
Digital Span Test Scale
Time frame: 1 day
To assess the subjects' attention span, forward and backward number spans were the subjects' ability to recite a series of numbers in the correct order.Participants were asked to repeat a series of random numbers in reverse order, reading each number for one second.Participants were asked to repeat the number in reverse order.Each set of numbers was randomly composed of the numbers 1 to 9, and the highest success score was calculated.The most successful scores were back-to-back 10 points and back-to-back 8 points.The higher the score, the better.
Stroop Color Word Test Scale
Time frame: 1 day
The executive ability of the subjects was assessed by the number of questions correctly answered by the subjects within 1min, which was divided into three types of cards: A, B and C, and each card had 100 items.Subjects correctly read the total number of red, blue, and green color names printed in black on card A within 1min, correctly identify the total number of red, blue, and green color backgrounds on card B within 1min, and correctly read the total number of different colors with red, blue, and green names on card C within 1min.For all parts of the Stroop test, the result is the time required to complete the C-card task, and the correct number, which is a kind of executive function test.The longer it takes, the worse the result, the higher the correct number, the better.
Trail Making Test A and B Scale
Time frame: 1 day
Test A: Show the numbers from 1 to 25. They are randomly distributed. Connect them in the order of 1, 2, 3, all the way to 25.Test B: There are numbers 1 to 13, black and white, respectively, in the order of the color black and white cameras, such as white 1 with black 1, black 1 with white 2, white 2 with black 2, all the way to 13.the higher scores mean a worse outcome.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2021.
Individual participant dataSharing planned: No

Related trials for Insomnia Chronic

Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Recruiting
Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women
Chronic Insomnia During Perimenopause and Menopause
Not yet recruiting
Online Tai Chi Versus Digital CBT-I for Chronic Insomnia
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Not yet recruiting
Shiwei Anshen Granules for Chronic Insomnia
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Insomnia Chronic, run by Lili Cao at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pittsburgh sleep quality index scale (time frame: 1 day). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04996953.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2021; AzTrials last refreshed its copy on 2 Nov 2026.