InsomniaNCT07714772
A Study of Dimdazenil in Patients With Parkinson's Disease and Insomnia
An observational study of Insomnia and Parkinson's Disease (PD), run by Second Affiliated Hospital of Soochow University.
Trial summary
This study will use sleep parameters measured by polysomnography (PSG) as the primary means to evaluate the efficacy and safety of dimdazenil, a GABAA receptor partial agonist, in treating insomnia in Parkinson's disease patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, Parkinson's Disease (PD)
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Parkinson's disease with insomnia，aged ≥18 years, male or female
Who may be able to join
- Provide written informed consent voluntarily after full comprehension of the study.
- Be aged ≥18 years, male or female.
- Meet the diagnostic criteria for Parkinson's disease according to the Chinese Diagnostic Criteria for Parkinson's Disease (2016 Edition), with a modified Hoehn-Yahr stage ≤3.
- Have insomnia symptoms [reduced total sleep time (<6.5 h) and/or sleep-onset latency >30 min, and/or ≥2 nocturnal awakenings, early-morning awakening, or poor sleep quality], occurring at least three times per week, accompanied by daytime dysfunction or daytime distress, with adequate opportunity for sleep yet difficulty initiating or maintaining sleep, and that cannot be fully explained by another sleep-wake disorder; and have satisfactory control of Parkinson's disease motor symptoms [MDS-UPDRS Part III (ON state) score ≤30].
- Be on a stable anti-Parkinsonian medication regimen, defined as no change in the type, dosage, or frequency of anti-Parkinsonian drugs for at least 4 weeks prior to enrollment, with no motor fluctuations or dyskinesia.
- Have a clinical decision by the attending physician to initiate didazinin treatment per routine practice.
- Be able to undergo polysomnography (PSG) monitoring.
- Be conscious, capable of normal communication, and able to complete sleep diaries independently.
Who cannot join
- Have Parkinson-plus syndromes, secondary parkinsonism, or other non-idiopathic Parkinson's disease.
- Have used benzodiazepine sedative-hypnotics within 7 days prior to enrollment.
- Have other significant comorbidities, such as malignant tumors, or clinically significant impairment of cardiac, hepatic, or renal function.
- Have severe obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), respiratory insufficiency, or myasthenia gravis.
- Have known hypersensitivity to any component of didazinin.
- Have moderate-to-severe depression or anxiety, defined as a Hamilton Depression Rating Scale (HAMD) score ≥25 or a Hamilton Anxiety Rating Scale (HAMA) score ≥29.
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- Have a history of substance abuse (e.g., drug addiction or alcohol dependence).
- Have a history of epilepsy, schizophrenia, bipolar disorder, developmental delay, or cognitive impairment.
- Be pregnant or breastfeeding.
- Be unwilling or unable to comply with scheduled follow-up visits.
- Have any other condition that, in the investigator's judgment, would make the subject unsuitable for participation (e.g., anticipated inability to complete follow-up within 14 days, or concurrent use of other medications that may substantially interfere with sleep assessment and cannot be withdrawn).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Dimdazenil, a GABAA Receptor Partial Agonist, in the Treatment of Insomnia in Patients With Parkinson's Disease
This study will use sleep parameters measured by polysomnography (PSG) as the primary means to evaluate the efficacy and safety of dimdazenil, a GABAA receptor partial agonist, in treating insomnia in Parkinson's disease patients.
Read the detailed description
This study will enroll a total of 50 Parkinson's disease patients with insomnia, aged ≥18 years. Eligible subjects who meet the inclusion and exclusion criteria and are judged by the investigator to be suitable for the study drug will receive dimdazenil capsules at a dose of 2.5 mg per night, with a total treatment duration of 14 days，taken orally immediately before bedtime as prescribed.
The primary efficacy endpoint is the change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 14. Secondary endpoints include multiple objective and subjective sleep parameters derived from PSG and sleep diaries, daytime function assessed by validated scales, and Parkinson's disease symptoms.
- Conditions
- Insomnia, Parkinson's Disease (PD)
- Keywords
- Insomnia, Parkinson's disease, Daytime Function, effective, safety, dimdazenil
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients with insomnia, aged ≥18 years, male or female | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 14 of dimdazenil treatment
Total sleep time (TST) is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG).
Measured: Baseline, Night 14
Secondary outcomes (30)
Change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 1 of dimdazenil treatment
Total sleep time (TST) is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG).
Measured: baseline, Night 1
Change from baseline in Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) motor examination score after 14 days of dimdazenil treatment
Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) is the motor examination section of the MDS-UPDRS, used to assess the severity of motor symptoms in patients with Parkinson's disease. The MDS-UPDRS-III comprises 27 items across 14 categories, including facial expression, tremor, rigidity, bradykinesia, postural instability, and gait examination. Each item is scored on a 5-point Likert scale (ranging from 0 to 4), with a total score range of 0 to 108. Higher scores indicate more severe motor symptoms.
Measured: baseline, Day 14
Change from baseline in latency to persistent sleep (LPS) measured by polysomnography (PSG)
Latency to persistent sleep (LPS) is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG), defined as the time from the start of PSG recording to the onset of non-rapid eye movement (NREM) sleep stage 1。
Measured: baseline, Night 1，Night 14
Change from baseline in wake after sleep onset (WASO) measured by polysomnography (PSG)
Wake after sleep onset（WASO） is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG)。Polysomnography (PSG) is a medical device that comprehensively evaluates sleep quality by simultaneously recording more than 10 physiological parameters, including electroencephalography (EEG)。PSG is regarded as the "gold standard" for the diagnosis of sleep disorders.
Measured: baseline, Night 1，Night 14
Change from baseline in number of awakenings (NAW) measured by polysomnography (PSG)
Number of awakenings (NAW) is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG).
Measured: baseline, Night 1，Night 14
Change from baseline in sleep efficiency (SE) measured by polysomnography (PSG)
Sleep efficiency (SE) is calculated from the total sleep time (TST) and total time in bed (TIB) recorded automatically by PSG, with the formula: SE = TST / TIB × 100%.
Total sleep time (TST): The sum of the durations of all epochs scored as N1, N2, N3, and REM sleep in the PSG recording, excluding all epochs scored as "Wake".
Total time in bed (TIB): The total duration from the start of PSG recording (when the subject goes to bed and prepares to sleep) to the end of recording (when the subject gets out of bed and leaves).
Measured: baseline, Night 1，Night 14
Change from baseline in subjective total sleep time (sTST)
subjective total sleep time (sTST) is recorded in sleep diary
Measured: baseline, Day 14 under the treatment of dimdazenil
Change from baseline in subjective sleep onset latency (sSL)
sSL is recorded in sleep diary
Measured: baseline, Day 14 under the treatment of dimdazenil
Change from baseline in subjective wake after sleep onset (sWASO)
sWASO is recorded in sleep diary
Measured: baseline, Day 14 under the treatment of dimdazenil
Change from baseline in subjective number of awakenings (sNAW)
sNAW is recorded in sleep diary
Measured: baseline, Day 14 under the treatment of dimdazenil
Change from baseline in subjective sleep efficiency (sSE)
Subjective sleep efficiency (sSE) is calculated from the subjective total sleep time (sTST) and total time in bed (TIB) recorded by the subject via a sleep diary, using the formula: sSE = sTST / TIB × 100%.
Total time in bed (TIB): The total duration recorded by the subject from the time they go to bed and attempt to sleep to the time they get out of bed the next morning. Subjective total sleep time (sTST): The total sleep duration calculated by subtracting sleep latency (time to fall asleep) and wake after sleep onset (WASO) from the total time in bed (TIB).
Measured: baseline, Day 14 under the treatment of dimdazenil
Change from baseline in Insomnia Severity Index (ISI) total score
The Insomnia Severity Index (ISI) is a self-reported questionnaire used to assess the severity of insomnia in subjects. The ISI comprises 7 items grouped under 5 major domains. The total score is the sum of each individual item score, ranging from 0 to 28. Scores are interpreted as follows: 0-7: no clinically significant insomnia; 8-14: subthreshold insomnia; 15-21: clinical insomnia (moderate); 22-28: clinical insomnia (severe).
Measured: baseline, Day 14 under the treatment of dimdazenil
Changes from baseline in the Parkinson's Disease Sleep Scale (PDSS) total score and individual item scores after 14 days of dimdazenil treatment
The Parkinson's Disease Sleep Scale (PDSS) is a 15-item self-reported instrument specifically designed to evaluate nocturnal sleep disturbances and daytime functioning in patients with Parkinson's disease. Each item is scored from 0 to 10 (0 = extremely severe symptoms, 10 = no symptoms), with a total score ranging from 0 to 150. Higher scores indicate better sleep quality.
Measured: baseline, Day 14
PSG-recorded sleep time duration in NREM sleep stages 1（N1）
Sleep time duration in Non-rapid eye movement(NREM) sleep stages 1（N1） is derived from automatic recordings obtained via polysomnography (PSG).
Measured: baseline, Night 1, Night 14
PSG-recorded sleep time duration in NREM sleep stages 2（N2）
Sleep time duration in Non-rapid eye movement(NREM) sleep stages 2（N2） is derived from automatic recordings obtained via polysomnography (PSG).
Measured: baseline, Night 1, Night 14
PSG-recorded sleep time duration in NREM sleep stages 3（N3）
Sleep time duration in Non-rapid eye movement(NREM) sleep stages 3（N3） is derived from automatic recordings obtained via polysomnography (PSG).
Measured: baseline, Night 1, Night 14
PSG-recorded sleep time duration in REM sleep
Sleep time duration in rapid eye movement(REM) sleep is derived from automatic recordings obtained via polysomnography (PSG).
Measured: baseline, Night 1, Night 14
PSG-recorded sleep latency for N1 sleep
Sleep latency for N1 sleep is derived from automatic recordings obtained via polysomnography (PSG). N1 latency is defined as the time from sleep onset to the first occurrence of N1 sleep.
Measured: baseline, Night 1, Night 14
PSG-recorded sleep latency for N2 sleep
Sleep latency for N2 sleep is derived from automatic recordings obtained via polysomnography (PSG). N2 latency is defined as the time from sleep onset to the first occurrence of N2 sleep.
Measured: baseline, Night 1, Night 14
PSG-recorded sleep latency for N3 sleep
"Sleep latency for N3 sleep is derived from automatic recordings obtained via polysomnography (PSG). N3 latency is defined as the time from sleep onset to the first occurrence of N3 sleep. "
Measured: baseline, Night 1, Night 14
PSG-recorded sleep latency for REM sleep
Sleep latency for rapid eye movement(REM) sleep is derived from automatic recordings obtained via polysomnography (PSG). REM latency is defined as the time from sleep onset to the first occurrence of REM sleep.
Measured: baseline, Night 1, Night 14
the percentage of total sleep time accounted for by N1 sleep
The percentage of total sleep time spent in N1 sleep (N1%) was calculated using the following formula: N1% = (N1 duration / TST) × 100%, where N1 duration was defined as the total duration of epochs scored as N1 sleep on PSG, and TST was defined as the total duration of all sleep epochs (N1 + N2 + N3 + REM).
Measured: baseline, Night 1, Night 14
the percentage of total sleep time accounted for by N2 sleep
The percentage of total sleep time spent in N2 sleep (N2%) was calculated using the following formula: N2% = (N2 duration / TST) × 100%, where N2 duration was defined as the total duration of epochs scored as N2 sleep on PSG, and TST was defined as the total duration of all sleep epochs (N1 + N2 + N3 + REM).
Measured: baseline, Night 1, Night 14
the percentage of total sleep time accounted for by N3 sleep
The percentage of total sleep time spent in N3 sleep (N3%) was calculated using the following formula: N3% = (N3 duration / TST) × 100%, where N3 duration was defined as the total duration of epochs scored as N3 sleep on PSG, and TST was defined as the total duration of all sleep epochs (N1 + N2 + N3 + REM).
Measured: baseline, Night 1, Night 14
the percentage of total sleep time accounted for by REM sleep
The percentage of total sleep time spent in REM sleep (REM%) was calculated using the following formula: REM% = (REM duration / TST) × 100%, where REM duration was defined as the total duration of epochs scored as REM sleep on PSG, and TST was defined as the total duration of all sleep epochs (N1 + N2 + N3 + REM).
Measured: baseline, Night 1, Night 14
Fatigue assessment after 14 days of dimdazenil treatment
Fatigue will be assessed using the Flinders Fatigue Scale, and changes in scores from baseline will be evaluated after treatment. The Flinders Fatigue Scale is a self-reported instrument used to assess fatigue severity. It yields a total score ranging from 0 to 31, with higher scores reflecting more severe fatigue.
Measured: baseline, Day 14
Daytime sleepiness assessment after 14 days of dimdazenil treatment
Daytime sleepiness assessment will be assessed using the Epworth Sleepiness Scale (ESS), and changes in scores from baseline will be evaluated after treatment. The Epworth Sleepiness Scale is a self-reported instrument used to assess daytime sleepiness severity. It yields a total score ranging from 0 to 24, with higher scores reflecting more severe sleepiness.
Measured: baseline, Day 14
Attention and working memory assessment after 14 days of dimdazenil treatment
Attention and working memory assessment will be assessed using the Digit Symbol Substitution Test (DSST), and changes in scores from baseline will be evaluated after treatment. The Digit Symbol Substitution Test (DSST) is a self-reported instrument used to assess attention and working memory. In the Digit Symbol Substitution Test (DSST), the total number of symbols completed and the total number of errors made by the subjects will be recorded. A higher number of symbols completed and a lower number of errors indicate better attention and working memory function.
Measured: baseline, Day 14
Cognitive function assessment after 14 days of dimdazenil treatment
Cognitive function assessment will be assessed using the Trail Making Test-A (TMT-A), and changes in scores from baseline will be evaluated after treatment. The Trail Making Test-A (TMT-A) is a self-reported instrument used to assess cognitive function. In the Trail Making Test-A (TMT-A), the completion time and number of errors are recorded. Shorter completion times and fewer errors indicate better cognitive function.
Measured: baseline, Day 14
Incidence of adverse events during dimdazenil treatment
Measured: From date of signing the informed consent until the date of the end of study visit or early withdrawal, assessed up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion10 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Soochow University
- Sponsor type
- University, hospital or other
- Collaborators
- The Fourth Affiliated Hospital of Soochow University, Changshu Hospital of Traditional Chinese Medicine, The Second Affiliated Hospital of Jiaxing University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714772
- Sponsor's protocol ID
- LK2026076
- Status last verified
- Jun 2026
- First submitted
- 1 Jul 2026
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Dimdazenil, a GABAA Receptor Partial Agonist, in the Treatment of Insomnia in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT07714772
- Acronym / sponsor ID
- LK2026076
- Conditions
- Insomnia, Parkinson's Disease (PD)
- Keywords
- Insomnia, Parkinson's disease, Daytime Function, effective, safety, dimdazenil
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Collaborators
- The Fourth Affiliated Hospital of Soochow University, Changshu Hospital of Traditional Chinese Medicine, The Second Affiliated Hospital of Jiaxing University
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 20 Jul 2026 (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.
This study will use sleep parameters measured by polysomnography (PSG) as the primary means to evaluate the efficacy and safety of dimdazenil, a GABAA receptor partial agonist, in treating insomnia in Parkinson's disease patients.
Detailed description
This study will enroll a total of 50 Parkinson's disease patients with insomnia, aged ≥18 years. Eligible subjects who meet the inclusion and exclusion criteria and are judged by the investigator to be suitable for the study drug will receive dimdazenil capsules at a dose of 2.5 mg per night, with a total treatment duration of 14 days，taken orally immediately before bedtime as prescribed.
The primary efficacy endpoint is the change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 14. Secondary endpoints include multiple objective and subjective sleep parameters derived from PSG and sleep diaries, daytime function assessed by validated scales, and Parkinson's disease symptoms.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients with insomnia, aged ≥18 years, male or female | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parkinson's disease with insomnia，aged ≥18 years, male or female
Key inclusion criteria (8 listed)
- Provide written informed consent voluntarily after full comprehension of the study.
- Be aged ≥18 years, male or female.
- Meet the diagnostic criteria for Parkinson's disease according to the Chinese Diagnostic Criteria for Parkinson's Disease (2016 Edition), with a modified Hoehn-Yahr stage ≤3.
- Have insomnia symptoms [reduced total sleep time (<6.5 h) and/or sleep-onset latency >30 min, and/or ≥2 nocturnal awakenings, early-morning awakening, or poor sleep quality], occurring at least three times per week, accompanied by daytime dysfunction or daytime distress, with adequate opportunity for sleep yet difficulty initiating or maintaining sleep, and that cannot be fully explained by another sleep-wake disorder; and have satisfactory control of Parkinson's disease motor symptoms [MDS-UPDRS Part III (ON state) score ≤30].
- Be on a stable anti-Parkinsonian medication regimen, defined as no change in the type, dosage, or frequency of anti-Parkinsonian drugs for at least 4 weeks prior to enrollment, with no motor fluctuations or dyskinesia.
Key exclusion criteria (11 listed)
- Have Parkinson-plus syndromes, secondary parkinsonism, or other non-idiopathic Parkinson's disease.
- Have used benzodiazepine sedative-hypnotics within 7 days prior to enrollment.
- Have other significant comorbidities, such as malignant tumors, or clinically significant impairment of cardiac, hepatic, or renal function.
- Have severe obstructive sleep apnea (OSA), chronic obstructive pulmonary disease (COPD), respiratory insufficiency, or myasthenia gravis.
- Have known hypersensitivity to any component of didazinin.
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
Change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 14 of dimdazenil treatment
Time frame: Baseline, Night 14
Total sleep time (TST) is an objective sleep parameter derived from automatic recordings obtained via polysomnography (PSG).
30 secondary outcomes
Change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 1 of dimdazenil treatment
Time frame: baseline, Night 1
Change from baseline in Movement Disorder Society - Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS-III) motor examination score after 14 days of dimdazenil treatment
Time frame: baseline, Day 14
Change from baseline in latency to persistent sleep (LPS) measured by polysomnography (PSG)
Time frame: baseline, Night 1，Night 14
Change from baseline in wake after sleep onset (WASO) measured by polysomnography (PSG)
Time frame: baseline, Night 1，Night 14
Change from baseline in number of awakenings (NAW) measured by polysomnography (PSG)
Time frame: baseline, Night 1，Night 14
Change from baseline in sleep efficiency (SE) measured by polysomnography (PSG)
Time frame: baseline, Night 1，Night 14
Change from baseline in subjective total sleep time (sTST)
Time frame: baseline, Day 14 under the treatment of dimdazenil
Change from baseline in subjective sleep onset latency (sSL)
Time frame: baseline, Day 14 under the treatment of dimdazenil
Change from baseline in subjective wake after sleep onset (sWASO)
Time frame: baseline, Day 14 under the treatment of dimdazenil
Change from baseline in subjective number of awakenings (sNAW)
Time frame: baseline, Day 14 under the treatment of dimdazenil
Change from baseline in subjective sleep efficiency (sSE)
Time frame: baseline, Day 14 under the treatment of dimdazenil
Change from baseline in Insomnia Severity Index (ISI) total score
Time frame: baseline, Day 14 under the treatment of dimdazenil
Changes from baseline in the Parkinson's Disease Sleep Scale (PDSS) total score and individual item scores after 14 days of dimdazenil treatment
Time frame: baseline, Day 14
PSG-recorded sleep time duration in NREM sleep stages 1（N1）
Time frame: baseline, Night 1, Night 14
PSG-recorded sleep time duration in NREM sleep stages 2（N2）
Time frame: baseline, Night 1, Night 14
PSG-recorded sleep time duration in NREM sleep stages 3（N3）
Time frame: baseline, Night 1, Night 14
PSG-recorded sleep time duration in REM sleep
Time frame: baseline, Night 1, Night 14
PSG-recorded sleep latency for N1 sleep
Time frame: baseline, Night 1, Night 14
PSG-recorded sleep latency for N2 sleep
Time frame: baseline, Night 1, Night 14
PSG-recorded sleep latency for N3 sleep
Time frame: baseline, Night 1, Night 14
PSG-recorded sleep latency for REM sleep
Time frame: baseline, Night 1, Night 14
the percentage of total sleep time accounted for by N1 sleep
Time frame: baseline, Night 1, Night 14
the percentage of total sleep time accounted for by N2 sleep
Time frame: baseline, Night 1, Night 14
the percentage of total sleep time accounted for by N3 sleep
Time frame: baseline, Night 1, Night 14
the percentage of total sleep time accounted for by REM sleep
Time frame: baseline, Night 1, Night 14
Fatigue assessment after 14 days of dimdazenil treatment
Time frame: baseline, Day 14
Daytime sleepiness assessment after 14 days of dimdazenil treatment
Time frame: baseline, Day 14
Attention and working memory assessment after 14 days of dimdazenil treatment
Time frame: baseline, Day 14
Cognitive function assessment after 14 days of dimdazenil treatment
Time frame: baseline, Day 14
Incidence of adverse events during dimdazenil treatment
Time frame: From date of signing the informed consent until the date of the end of study visit or early withdrawal, assessed up to 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Insomnia and Parkinson's Disease (PD), run by Second Affiliated Hospital of Soochow University.
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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xy Cheng (0086 0512-67784179, chengxiaoyu2007@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in total sleep time (TST) measured by polysomnography (PSG) on the night of Day 14 of dimdazenil treatment (time frame: Baseline, Night 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2026.