Establishment of a Diagnosis and Treatment System for Information Processing Damage in Children With OSAHS

NCT04080089 | Unknown

• 1 other identifier: SAHoWMU-CR2018-06-220
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea hypopnea syndrome (OSAHS) is a common childhood sleep disorder with an incidence of 3% . Studies have confirmed that OSAHS can cause multiple systemic dysfunction in children, especially affecting cognitive function . Cognitive function is an important part of human advanced neurological activities, including neurobehavioral functions such as orientation, attention, concentration, alertness, behavior, execution, etc., as well as intelligence and verbal functions such as memory, learning, calculation, language, understanding, judgment, and logic. Reasoning and many other aspects. Impaired cognitive function often means poor academic performance, which is the most concern of parents. However, due to the limitations of cognitive assessment tools, most studies only conduct qualitative research on children's cognition, lack of quantitative research. . The underlying reason is that these studies lack the guidance of systematic intellectual theory and the support of cognitive quantitative assessment tools. At present, no one at home and abroad has systematically and comprehensively studied the cognitive impairment caused by OSAHS based on the most advanced cognitive theory. Modern cognitive science believes that cognition, including human memory, decision, reasoning, classification, and planning, is an ability that can be added to "the treatment may change." Some skill and intelligence of human beings at a certain level of cognitive activity can be trained in the execution of certain practices and in the completion of a plan. Scenes, situational features, and tasks, whether material or symbolic, play an important role in human training techniques. Therefore, evaluable and scientific cognitive function training for individuals is beneficial to the development of cognitive function, especially for the treatment training of patients with cognitive dysfunction. At present, the treatment of OSAHS is mainly for the treatment of primary disease such as oropharyngeal surgery, CPAP, etc. These treatments

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• Evaluating information processing

  Different treatments were chosen to treat patients with OSAHS. After treatment, the digital remote DNCAS cognitive evaluation system was used to evaluate the information processing process of the child. Compare with pre-treatment and explore whether there is a difference in the treatment effect of each treatment method on children with different subtypes of information processing.

  6 months

Study Arms (2)

Case group

Children over the age of 6 who came to the outpatient clinic of our hospital received the informed consent of the parents, and then included in the case group, conducted a self-made sleep questionnaire, established a file, and monitored the sleep on the Mofeh Time Sleep Apnea Monitor. The results were uploaded to the cloud system for analysis. 50 children with OSAHS were screened. Voluntary participation in the study; ability to complete all tests as well as magnetic resonance studies. Exclusion criteria: 1 mental retardation, generalized developmental disorders, severe physical and endocrine diseases, neurological diseases and other mental disorders; 2 visual and auditory diseases affecting the processing of cognitive information. 3 Psychiatric drugs were used in January.

Combination Product: Surgical treatment, drug therapy, remote cognitive training

Control group

Children in the same age group of children with health checkups were screened for sleep and questionnaires without sleep. After receiving parental informed consent, 30 children were included in the control group. Exclusion criteria: 1 mental retardation, generalized developmental disorder, learning disabilities, conduct Disorders, severe physical and endocrine diseases, neurological diseases and other mental illnesses. 2 There are visual and auditory diseases that affect the processing of cognitive information.

Interventions

Surgical treatment, drug therapy, remote cognitive training COMBINATION_PRODUCT

Surgical treatment：Children with OSAHS who had surgical indications and informed consent from the parents underwent tonsillectomy and adenoidectomy. drug therapy：For children whose parents only agree to receive medical treatment, montelukast sodium tablets are given for 6 months to reduce the inflammatory response of adenoids, tonsils, etc. remote cognitive training:For children whose parents did not agree to undergo surgery or medication, the cognitive function was evaluated at the time of enrollment, and cognitive training was performed. Individualized training programs were developed according to the cognitive assessment system, and cognitive function was evaluated again after one course of treatment.

Case group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Case group: Children（\>6years old）who have snoring will be included in the case group after receiving informed consent from the parents. A sleep questionnaire will be conducted. The results were uploaded for analysis and 50 children with OSAHS were screened. Voluntary participation in the study; ability to complete all tests as well as magnetic resonance studies. Exclusion criteria: 1 mental retardation, generalized developmental disorders, severe physical and endocrine diseases, neurological diseases and other mental disorders; 2 visual and auditory diseases affecting the processing of cognitive information. 3 used psychiatric drugs in the past 1 month Control group: 30 Healthy children in the same age group, without OSAHS, received parental informed consent.Exclusion criteria: Same

You may qualify if:

• Case group - Children over 6 years old who have snoring in our outpatient clinic Control group - Children in the same age group of children with health checkups, screened by sleep questionnaire and sleep monitoring without OSAHS

You may not qualify if:

• Case group - 1 mental retardation, extensive developmental disorders, severe physical and endocrine diseases, neurological diseases and other mental disorders; 2 there are visual and auditory diseases affecting the processing of cognitive information. 3 Psychiatric drugs have been used in the past 1 month.
• Control group -1 mental retardation, generalized developmental disorders, learning disabilities, conduct disorders, severe physical and endocrine diseases, neurological diseases and other mental illnesses. 2 There are visual and auditory diseases that affect the processing of cognitive information.

Sponsors & Collaborators

• Second Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

SAHWenzhouMU

Wenzhou, Zhejiang, 325000, China

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Surgical Procedures, Operative; Drug Therapy

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Xiaohong Cai, M.D.

  Second Affiliated Hospital of Wenzhou Medical University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: October 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

CN (1)