Relationship of Nocturnal Concentrations of Melatonin, γ-aminobutyric Acid and Total Antioxidants With Insomnia

NCT03202121 | Unknown DMC

• 1 other identifier: ChinaRRC_01
• Study Type: observational
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

To analyze the relationship of nocturnal concentrations of melatonin, γ-aminobutyric acid and total antioxidants with insomnia after stroke.

Conditions

Insomnia

Outcome Measures

Primary Outcomes (1)

• Nocturnal concentrations of melatonin

  Melatonin is a pineal hormone with the peak nocturnal secretion. Melatonin typically takes a large responsibility in coordination with the circadian rhythms and further serves as a regulator in the sleep function. The secretion peak of melatonin is around midnight to 3:00 a.m.. Along with other antioxidants, the melatonin can also work as an effective neuroprotective enzyme against neurodegeneration and ischemic brain injury. Thus, the melatonin is known to take an important role in acute ischemic stroke, with a rhythm impairment and nocturnal decrease.

  1 day at 3:00 a.m

Secondary Outcomes (1)

• National Institute of Health Stroke Scale

  1 day at 3:00 a.m

Study Arms (3)

insomnia group

After screening according to inclusion and exclusion criteria, patients were assigned to insomnia group that contained 25 cases.

Other: insomnia group

non-insomnia group

After screening according to inclusion and exclusion criteria, patients were assigned to non-insomnia group that contained 25 cases.

Other: non-insomnia group

normal control

persons without stroke or insomnia served as normal controls that contained 25 cases.

Other: normal control

Interventions

insomnia group OTHER

After screening according to inclusion and exclusion criteria, patients were assigned to insomnia group that contained 25 cases.

insomnia group

non-insomnia group OTHER

After screening according to inclusion and exclusion criteria, patients were assigned to non-insomnia group that contained 25 cases.

non-insomnia group

normal control OTHER

Persons without stroke or insomnia served as normal controls that contained 25 cases.

normal control

Eligibility Criteria

• Age: 50 Years - 70 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is a prospective single-center randomized controlled clinical trial in the China Rehabilitation Research Center. Stroke patients during rehabilitation have been recruited since July in 2014. After screening according to inclusion and exlcusion criteria, patients were assigned to insomnia group and non-insomnia group. Simultaneously, persons without stroke or insomnia served as normal controls. Each group contained 25 cases.

You may qualify if:

• Infarction occurred in the middle cerebral artery blood supply area (Identified by medical record, magnetic resonance imaging, magnetic resonance angiography, computed tomography or computed tomography angiogram)
• Diagnostic criteria for insomnia of Diagnostic and Statistical Manual of Mental Disorders (4th edition)
• Course of disease ≥ 3 months
• Mini-Mental State Examination \> 27
• Age ranged from 50 to 70 years old
• Right handedness

You may not qualify if:

• Cognitive and language disorders
• History of rheumatism, cancer, severe liver and kidney dysfunction, benign prostatic hyperplasia, and severe cardiac insufficiency, besides hypertension, diabetes, and coronary atherosclerotic heart disease
• High-risk sleep apnea, i.e., STOP-Bang Questionnaire ≥ 3
• Unexplained limb pain, many times of getting up in the night to urinate or restless legs syndrome
• Frequency of application of sleeping drugs \> once/week or the use of psychotropic drugs, such as anti-anxiety and depression drugs, and antipsychotic drugs
• Frequency of drinking coffee and other stimulating drinks \> three times/week
• Drug or alcohol abuse
• Insomnia caused by poor sleeping conditions, such as noise, light, and bedmate interference
• Insomnia before affecting stroke
• Hamilton Depression Scale \> 20 or Hamilton Anxiety Scale \> 14
• Participation in other clinical trials

Sponsors & Collaborators

• China Rehabilitation Research Center: lead

Related Publications (1)

• Zhang W, Li F, Zhang T. Relationship of nocturnal concentrations of melatonin, gamma-aminobutyric acid and total antioxidants in peripheral blood with insomnia after stroke: study protocol for a prospective non-randomized controlled trial. Neural Regen Res. 2017 Aug;12(8):1299-1307. doi: 10.4103/1673-5374.213550.

  PMID: 28966645 DERIVED

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Wei Zhang, Ph.D

  China Rehabilitation Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: June 28, 2017
• Study Start: July 1, 2011
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: July 18, 2018

Record last verified: 2018-07