Allergic RhinitisNCT03714945
Study on Association Between Treatment of Allergic Rhinitis and Cognitive Ability in Children
An observational study of Allergic Rhinitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Allergic Rhinitis
- How many people
- 174 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2017to 31 Dec 2020
- 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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- Control Group- Inclusion Criteria
- Both genders of 11-14 years
- Chinese in ethnicity
- Subjects who have not been diagnosed with a long term medical or psychiatric problem
- Subjects who are not currently undergoing any long term medical treatment.
- Patient Group- Inclusion Criteria
Show all 11Show fewer
- 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)
- Chinese in ethnicity
- Positive skin prick test with wheal diameter >= 3mm
- Ability to understand the nature, scope, and possible consequences of the study
- Capability and willingness to comply with the requirements of the protocol
Who cannot join
- 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)
- Subjects with prior nasal surgery (e.g. nasal cavity, sinuses)
- Subjects with known brain disorders, prior brain surgery or history of stroke
- Subjects diagnosed with learning disability, autism or attention deficit hyperactivity disorder (ADHD)
- 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
- Subjects who have taken topical nasal steroids, oral anti-histamines or medications affecting nasal symptoms 30 days prior to commencement of study
Show all 11Show fewer
- Subjects with hypersensitivity reactions towards topical nasal steroids or oral anti-histamines
- Subjects previously diagnosed with any psychiatric disorders
- Subjects who suffered from a respiratory tract infection within the past 30 days
- Subjects who have clinically major cardiovascular, respiratory, hepatic, neurological, endocrine, immunological or other major systemic disease(s)
- Subjects who are undergoing a long-term medical treatment plan
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Department of Otorhinolaryngology, Head and Neck Surgery
Hong Kong, 00000
Calvin Pok Hong PH Lam, MSSc,MA,BSSc, 852-3505-3395, calvinlam@link.cuhk.edu.hk
Janice Su Chuen SC Lin, MBChB
About this study
Official title: 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.
Read the 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
- To investigate, if any, the differences between normal and allergic rhinitis patients in terms of cognitive function
- To investigate the impact of allergic rhinitis on different areas of cognitive function
- 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.
- Conditions
- Allergic Rhinitis
- Being tested
- No intervention
- Keywords
- Allergic Rhinitis, Children, Cognitive Ability
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention is required as this study is observational.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: No intervention | |
| 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. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trait Making Test (TMT)
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.
Measured: 8 weeks
Secondary outcomes (5)
Rhinitis Symptom Utility Index (RSUI)
Examining the self-reported severity of Rhinitis symptoms. The low score the subject obtained, the more severe level in Allergic Rhinitis symptoms observed.
Measured: 8 weeks
Stroop Test (Chinese Translated Victoria Version)
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.
Measured: 8 weeks
Digit Span Test (DST)
It tests the number of correct sequences of a series of digit. Longer sequence of a series of digit denotes higher score.
Measured: 8 weeks
Chinese Auditory Verbal Learning Test
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.
Measured: 8 weeks
Verbal Fluency Test
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 Dec 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Tong, Chinese University of Hong Kong
- Investigators
- Michael Chi Fai CF Tong, MD, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714945
- Sponsor's protocol ID
- CREC Ref No.: 2017.548
- Status last verified
- Jun 2019
- First submitted
- 22 Sep 2018
- Last updated
- 26 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to make individual participant data (IPD) available to other researchers.
Publications
New Publication by HKU Paediatricians : 'Allergic Rhinitis - The Paediatric Disease You Must Learn' - All News - Media - HKU. (n.d.). Retrieved October 10, 2017, from http://www.hku.hk/press/news_detail_6527.html
Aetiology of allergic rhinitis in Hong Kong. (2015, March 19). Retrieved October 10, 2017, from http://www.sciencedirect.com/science/article/pii/S1323893015315343
Vuurman EF, Vuurman LL, Lutgens I, Kremer B. Allergic rhinitis is a risk factor for traffic safety. Allergy. 2014 Jul;69(7):906-12. doi: 10.1111/all.12418. Epub 2014 May 9.
PubMed 24815889Allergic rhinitis: impact, diagnosis, treatment and management. (2016, August 09). Retrieved October 10, 2017, from http://www.pharmaceutical-journal.com/research/review-article/allergic-rhinitis-impact-diagnosis-treatment-and-management/20201509.article
Walker S, Khan-Wasti S, Fletcher M, Cullinan P, Harris J, Sheikh A. Seasonal allergic rhinitis is associated with a detrimental effect on examination performance in United Kingdom teenagers: case-control study. J Allergy Clin Immunol. 2007 Aug;120(2):381-7. doi: 10.1016/j.jaci.2007.03.034. Epub 2007 Jun 8.
PubMed 17560637Jauregui I, Mullol J, Davila I, Ferrer M, Bartra J, del Cuvillo A, Montoro J, Sastre J, Valero A. Allergic rhinitis and school performance. J Investig Allergol Clin Immunol. 2009;19 Suppl 1:32-9.
PubMed 19476052Kim DK, Rhee CS, Han DH, Won TB, Kim DY, Kim JW. Treatment of allergic rhinitis is associated with improved attention performance in children: the Allergic Rhinitis Cohort Study for Kids (ARCO-Kids). PLoS One. 2014 Oct 17;9(10):e109145. doi: 10.1371/journal.pone.0109145. eCollection 2014.
PubMed 25330316Lo PS, Tong MC, Revicki DA, Lee CC, Woo JK, Lam HC, van Hasselt CA. Rhinitis Symptom Utility Index (RSUI) in Chinese subjects: a multiattribute patient-preference approach. Qual Life Res. 2006 Jun;15(5):877-87. doi: 10.1007/s11136-005-4828-x.
PubMed 16721647Lee T, Yuen K, Chan C. Normative data for neuropsychological measures of fluency, attention, and memory measures for Hong Kong Chinese. J Clin Exp Neuropsychol. 2002 Aug;24(5):615-32. doi: 10.1076/jcen.24.5.615.1001.
PubMed 12187445Hitch JG, McAuley E. Working memory in children with specific arithmetical learning difficulties. Br J Psychol. 1991 Aug;82 ( Pt 3):375-86. doi: 10.1111/j.2044-8295.1991.tb02406.x.
PubMed 1954527Kremer B, den Hartog HM, Jolles J. Relationship between allergic rhinitis, disturbed cognitive functions and psychological well-being. Clin Exp Allergy. 2002 Sep;32(9):1310-5. doi: 10.1046/j.1365-2745.2002.01483.x.
PubMed 12220469Den Hartog HM, Derix MM, Van Bemmel AL, Kremer B, Jolles J. Cognitive functioning in young and middle-aged unmedicated out-patients with major depression: testing the effort and cognitive speed hypotheses. Psychol Med. 2003 Nov;33(8):1443-51. doi: 10.1017/s003329170300833x.
PubMed 14672253Pendleton MG, Heaton RK, Lehman RA, Hulihan D. Diagnostic utility of the Thurstone Word Fluency Test in neuropsychological evaluations. J Clin Neuropsychol. 1982 Dec;4(4):307-17. doi: 10.1080/01688638208401139.
PubMed 7174838Ardila A, Pineda D, Rosselli M. Correlation between intelligence test scores and executive function measures. Arch Clin Neuropsychol. 2000 Jan;15(1):31-6.
PubMed 14590565Norrman G, Falth-Magnusson K. Adverse reactions to skin prick testing in children - prevalence and possible risk factors. Pediatr Allergy Immunol. 2009 May;20(3):273-8. doi: 10.1111/j.1399-3038.2008.00761.x. Epub 2009 Feb 10.
PubMed 19220772
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Longitudinal Study on the Association Between Treatment of Allergic Rhinitis and Cognitive Ability in Children
- ClinicalTrials.gov ID
- NCT03714945
- Acronym / sponsor ID
- CREC Ref No.: 2017.548
- Conditions
- Allergic Rhinitis
- Keywords
- Allergic Rhinitis, Children, Cognitive Ability
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 22 Oct 2018 (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.
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.
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
- To investigate, if any, the differences between normal and allergic rhinitis patients in terms of cognitive function
- To investigate the impact of allergic rhinitis on different areas of cognitive function
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case Group with Allergic Rhinitis | – | Other: No intervention- 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 |
| Control Group without Allergic Rhinitis | – | Other: No intervention- 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. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (11 listed)
- Control Group- Inclusion Criteria
- Both genders of 11-14 years
- Chinese in ethnicity
- Subjects who have not been diagnosed with a long term medical or psychiatric problem
- Subjects who are not currently undergoing any long term medical treatment.
Key exclusion criteria (11 listed)
- 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)
- Subjects with prior nasal surgery (e.g. nasal cavity, sinuses)
- Subjects with known brain disorders, prior brain surgery or history of stroke
- Subjects diagnosed with learning disability, autism or attention deficit hyperactivity disorder (ADHD)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention is required as this study is observational. | Other | Case Group with Allergic Rhinitis, Control Group without Allergic Rhinitis |
Primary outcome
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.
5 secondary outcomes
Rhinitis Symptom Utility Index (RSUI)
Time frame: 8 weeks
Stroop Test (Chinese Translated Victoria Version)
Time frame: 8 weeks
Digit Span Test (DST)
Time frame: 8 weeks
Chinese Auditory Verbal Learning Test
Time frame: 8 weeks
Verbal Fluency Test
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- BackgroundNew Publication by HKU Paediatricians : 'Allergic Rhinitis - The Paediatric Disease You Must Learn' - All News - Media - HKU. (n.d.). Retrieved October 10, 2017, from http://www.hku.hk/press/news_detail_6527.html
- BackgroundAetiology of allergic rhinitis in Hong Kong. (2015, March 19). Retrieved October 10, 2017, from http://www.sciencedirect.com/science/article/pii/S1323893015315343
- Background: PubMed 24815889Vuurman EF, Vuurman LL, Lutgens I, Kremer B. Allergic rhinitis is a risk factor for traffic safety. Allergy. 2014 Jul;69(7):906-12. doi: 10.1111/all.12418. Epub 2014 May 9.
- BackgroundAllergic rhinitis: impact, diagnosis, treatment and management. (2016, August 09). Retrieved October 10, 2017, from http://www.pharmaceutical-journal.com/research/review-article/allergic-rhinitis-impact-diagnosis-treatment-and-management/20201509.article
- Background: PubMed 17560637Walker S, Khan-Wasti S, Fletcher M, Cullinan P, Harris J, Sheikh A. Seasonal allergic rhinitis is associated with a detrimental effect on examination performance in United Kingdom teenagers: case-control study. J Allergy Clin Immunol. 2007 Aug;120(2):381-7. doi: 10.1016/j.jaci.2007.03.034. Epub 2007 Jun 8.
- Background: PubMed 19476052Jauregui I, Mullol J, Davila I, Ferrer M, Bartra J, del Cuvillo A, Montoro J, Sastre J, Valero A. Allergic rhinitis and school performance. J Investig Allergol Clin Immunol. 2009;19 Suppl 1:32-9.
- Background: PubMed 25330316Kim DK, Rhee CS, Han DH, Won TB, Kim DY, Kim JW. Treatment of allergic rhinitis is associated with improved attention performance in children: the Allergic Rhinitis Cohort Study for Kids (ARCO-Kids). PLoS One. 2014 Oct 17;9(10):e109145. doi: 10.1371/journal.pone.0109145. eCollection 2014.
- Background: PubMed 16721647Lo PS, Tong MC, Revicki DA, Lee CC, Woo JK, Lam HC, van Hasselt CA. Rhinitis Symptom Utility Index (RSUI) in Chinese subjects: a multiattribute patient-preference approach. Qual Life Res. 2006 Jun;15(5):877-87. doi: 10.1007/s11136-005-4828-x.
- Background: PubMed 12187445Lee T, Yuen K, Chan C. Normative data for neuropsychological measures of fluency, attention, and memory measures for Hong Kong Chinese. J Clin Exp Neuropsychol. 2002 Aug;24(5):615-32. doi: 10.1076/jcen.24.5.615.1001.
- Background: PubMed 1954527Hitch JG, McAuley E. Working memory in children with specific arithmetical learning difficulties. Br J Psychol. 1991 Aug;82 ( Pt 3):375-86. doi: 10.1111/j.2044-8295.1991.tb02406.x.
- Background: PubMed 12220469Kremer B, den Hartog HM, Jolles J. Relationship between allergic rhinitis, disturbed cognitive functions and psychological well-being. Clin Exp Allergy. 2002 Sep;32(9):1310-5. doi: 10.1046/j.1365-2745.2002.01483.x.
- Background: PubMed 14672253Den Hartog HM, Derix MM, Van Bemmel AL, Kremer B, Jolles J. Cognitive functioning in young and middle-aged unmedicated out-patients with major depression: testing the effort and cognitive speed hypotheses. Psychol Med. 2003 Nov;33(8):1443-51. doi: 10.1017/s003329170300833x.
- Individual participant dataSharing planned: No. No plan to make individual participant data (IPD) available to other researchers.
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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.
Michael Chi Fai CF Tong, MD, MBChB principal investigator
Chinese University of Hong Kong
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 Allergic Rhinitis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 11 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: status not confirmed, as of the sponsor's last update on 26 Jun 2019. 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 Hong Kong. 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?
Contact Calvin Pok Hong PH LAM, MSSc,MA,BSSc (852-35053395, calvinlam@link.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trait Making Test (TMT) (time frame: 8 weeks). 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 NCT03714945, which also lists 19 linked publications.
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 26 Jun 2019.