Study on Association Between Treatment of Allergic Rhinitis and Cognitive Ability in Children

June 25, 2019 updated by: Michael Tong, Chinese University of Hong Kong

Prospective Longitudinal Study on the Association Between Treatment of Allergic Rhinitis and Cognitive Ability in Children

Pilot study on the association between allergic rhinitis and cognitive ability in 174 children aged 11-14 within the same year group at school in which 140 Allergic Rhinitis subjects and 34 non-Allergic Rhinitis subjects. Primary outcome measures include cognitive tests (Trait Making Test, Digit Span Test, Stroop Test, Chinese Auditory Verbal Learning Test, Verbal Fluency Test), so as to assess the cognitive ability of allergic rhinitis patients before and after treatment compared to a control group. Rhinitis Symptom Utility Index (RSUI) of patients will be the secondary outcome measured through questionnaires. Positive skin prick test and endoscopy examination (taking place in Prince of Wales hospital) will be required before the diagnosis of allergic rhinitis. The data will be analysed by the Multilevel models.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

INTRODUCTION Allergic rhinitis is the reportedly second most common reported chronic health condition in Hong Kong children under the age of 14, with the Child Health Survey 2005-2006 indicating a prevalence of 24.5%. Allergic rhinitis is a type I hypersensitivity reaction, which occurs when IgE antibodies are produced against allergens, leading to the activation of mast cells which release inflammatory mediators. Common allergens in Hong Kong include house dust mite and cockroaches. Allergic rhinitis causes a multitude of symptoms including itching, sneezing, nasal discharge, post-nasal drip, and nasal congestion. It can cause poor quality sleep, leading to daytime sleepiness, decreased cognitive ability, mood instability and fatigue. Allergic rhinitis leading to a reduction in quality of life in adults has been well established, leading to impediment of cognitive processes and poorer ability in attention-requiring activities (e.g. driving). These symptoms can similarly significantly impede a child's education and quality of life. It is estimated that up to 90% of allergic rhinitis patients are untreated, insufficiently treated, or inappropriately treated.

With regards to children and teenagers, some studies have suggested that allergic rhinitis can cause significant cognitive difficulties, with detrimental effects on children's education and examination performance, however others suggest there is no association. A longitudinal cohort study in 2014 on the treatment of allergic rhinitis in children showed an improvement in attention and divided attention after 1 year of treatment. There are little studies regarding the effect of treatment of allergic rhinitis on cognitive abilities in children.

RESEARCH OBJECTIVES

  1. To investigate, if any, the differences between normal and allergic rhinitis patients in terms of cognitive function
  2. To investigate the impact of allergic rhinitis on different areas of cognitive function
  3. To investigate the improvement of cognitive function in children after 8 weeks of standard treatment of allergic rhinitis

RESEARCH HYPOTHESIS Children with allergic rhinitis are expected to have a heightened improvement in cognitive abilities after the treatment compared to the normal control group due to relief of their nasal symptoms.

STUDY DESIGN This study is a prospective longitudinal pilot study to take place from 15 1 Nov Dec 2017 to 31 Dec 2018. Final report will be completed 30 June 2019.

STUDY SAMPLE AND SETTING The study is to be performed in Hong Kong, with subjects aged 11-14 studying Form 1 and 2 in secondary school being recruited. Recruitment and cognitive testing will take place at the secondary school, whilst physician follow up and skin prick tests will take place at Prince of Wales Hospital. Healthy individuals as well as patients with a history of allergic rhinitis will be recruited. Chinese will be the main language used. The total number of the Form 1 students within the school will be around 200. The estimated participation rate will be approximately 70%. As the prevalence of allergic rhinitis in Hong Kong children under the age of 14 is approximately 24.5%, the expected number of Allergic Rhinitis participants and non-Allergic Rhinitis participants are 140 and 34 respectively.

Study Type

Observational

Enrollment (Anticipated)

174

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong, 00000
        • Recruiting
        • Department of Otorhinolaryngology, Head and Neck Surgery
        • Contact:
        • Sub-Investigator:
          • Janice Su Chuen SC Lin, MBChB
        • Sub-Investigator:
          • Ronald R Lai, MBChB
        • Sub-Investigator:
          • Eric Yan Ching YC Tse, MSSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 14 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Students aged 11 to 14 currently studying Form 1 and 2 currently studying in secondary schools in Hong Kong will be recruited directly through invitation. Recruitment will include patients suffering from untreated allergic rhinitis in additional to healthy individuals to serve as a control group. Patients suffering from allergic rhinitis will be classified according to ARIA guidelines into mild/moderate/severe, and duration into intermittent/persistent. Patients suffering from rhinitis due to non-allergic origins or those associated with nasal polyposis or sinusitis will be excluded. Patients are going to complete the Rhinitis Symptom Utility Index (RSUI) questionnaire for assessing pre and post symptoms.

Description

Inclusion Criteria:

- Control Group- Inclusion Criteria

  1. Both genders of 11-14 years
  2. Chinese in ethnicity
  3. Subjects who have not been diagnosed with a long term medical or psychiatric problem
  4. Subjects who are not currently undergoing any long term medical treatment.

Patient Group- Inclusion Criteria

  1. Both genders of 11-14 years, diagnosed with allergic rhinitis on basis of screening instruments, medical history, clinical assessment (by general ORL examination including nasal endoscopy)
  2. Chinese in ethnicity
  3. Positive skin prick test with wheal diameter >= 3mm
  4. Ability to understand the nature, scope, and possible consequences of the study
  5. Capability and willingness to comply with the requirements of the protocol

Exclusion Criteria:

  1. Subjects with co-existing nasal conditions other than AR, which may affect nasal pathology (nasal polyposis, sinusitis, severe deviations of nasal septum, tumours of the nasal cavity, acute/chronic rhinosinusitis or any underlying pathology that might affect nasal breathing or nocturnal sleep)
  2. Subjects with prior nasal surgery (e.g. nasal cavity, sinuses)
  3. Subjects with known brain disorders, prior brain surgery or history of stroke
  4. Subjects diagnosed with learning disability, autism or attention deficit hyperactivity disorder (ADHD)
  5. Subjects with history of known sleep disorder, central or obstructive sleep apnea, narcolepsy, insomnia, patients requiring regular sleep medication and those hypersensitive to applied topical nasal steroids
  6. Subjects who have taken topical nasal steroids, oral anti-histamines or medications affecting nasal symptoms 30 days prior to commencement of study
  7. Subjects with hypersensitivity reactions towards topical nasal steroids or oral anti-histamines
  8. Subjects previously diagnosed with any psychiatric disorders
  9. Subjects who suffered from a respiratory tract infection within the past 30 days
  10. Subjects who have clinically major cardiovascular, respiratory, hepatic, neurological, endocrine, immunological or other major systemic disease(s)
  11. Subjects who are undergoing a long-term medical treatment plan

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case Group with Allergic Rhinitis

- Inclusion Criteria

  1. Both genders of 11-14 years, diagnosed with allergic rhinitis on basis of screening instruments, medical history, clinical assessment (by general ORL examination including nasal endoscopy)
  2. Chinese in ethnicity
  3. Positive skin prick test with wheal diameter >= 3mm
  4. Ability to understand the nature, scope, and possible consequences of the study
  5. Capability and willingness to comply with the requirements of the protocol
Other: No intervention
No intervention is required as this study is observational.
Control Group without Allergic Rhinitis

- Inclusion Criteria

  1. Both genders of 11-14 years
  2. Chinese in ethnicity
  3. Subjects who have not been diagnosed with a long term medical or psychiatric problem
  4. Subjects who are not currently undergoing any long term medical treatment.
Other: No intervention
No intervention is required as this study is observational.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trait Making Test (TMT)
Time Frame: 8 weeks
It tests how fast and accurate the subjects can connect all numbered dots and alphabets in specified instruction. Shorted completion time with accurate compliance to instructions denotes higher score.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rhinitis Symptom Utility Index (RSUI)
Time Frame: 8 weeks
Examining the self-reported severity of Rhinitis symptoms. The low score the subject obtained, the more severe level in Allergic Rhinitis symptoms observed.
8 weeks
Stroop Test (Chinese Translated Victoria Version)
Time Frame: 8 weeks
It tests how fast and accurate subjects call the name of color on alphabet but not the name of the alphabet. Shorter time with accurate identification denotes higher score.
8 weeks
Digit Span Test (DST)
Time Frame: 8 weeks
It tests the number of correct sequences of a series of digit. Longer sequence of a series of digit denotes higher score.
8 weeks
Chinese Auditory Verbal Learning Test
Time Frame: 8 weeks
It tests the short-term memory and delayed memory after listening to a series of words in few trials. More words remembered means higher score.
8 weeks
Verbal Fluency Test
Time Frame: 8 weeks
It tests the verbal fluency of subject who names words in specific topic. More words name within a certain period of time means higher score obtained.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Michael Chi Fai CF Tong, MD, MBChB, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2017

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

September 22, 2018

First Submitted That Met QC Criteria

October 19, 2018

First Posted (Actual)

October 22, 2018

Study Record Updates

Last Update Posted (Actual)

June 26, 2019

Last Update Submitted That Met QC Criteria

June 25, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC Ref No.: 2017.548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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