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

NCT03714945 | Unknown DMC

• 1 other identifier: CREC Ref No.: 2017.548
• Study Type: observational
• Target: 174
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Allergic Rhinitis

Keywords

Allergic Rhinitis; Children; Cognitive Ability

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (5)

• Rhinitis Symptom Utility Index (RSUI)

  8 weeks

• Stroop Test (Chinese Translated Victoria Version)

  8 weeks

• Digit Span Test (DST)

  8 weeks

• Chinese Auditory Verbal Learning Test

  8 weeks

• Verbal Fluency Test

  8 weeks

Study Arms (2)

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

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

Interventions

No intervention OTHER

No intervention is required as this study is observational.

Case Group with Allergic Rhinitis; Control Group without Allergic Rhinitis

Eligibility Criteria

• Age: 11 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Otorhinolaryngology, Head and Neck Surgery

Hong Kong, 00000, Hong Kong

RECRUITING

Related Publications (19)

• 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

  BACKGROUND

• Aetiology of allergic rhinitis in Hong Kong. (2015, March 19). Retrieved October 10, 2017, from http://www.sciencedirect.com/science/article/pii/S1323893015315343

  BACKGROUND

• 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.

  PMID: 24815889 BACKGROUND

• Allergic 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

• 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.

  PMID: 17560637 BACKGROUND

• Jauregui 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.

  PMID: 19476052 BACKGROUND

• Kim 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.

  PMID: 25330316 BACKGROUND

• Lo 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.

  PMID: 16721647 BACKGROUND

• Lee 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.

  PMID: 12187445 BACKGROUND

• Hitch 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.

  PMID: 1954527 BACKGROUND

• Kremer 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.

  PMID: 12220469 BACKGROUND

• Den 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.

  PMID: 14672253 BACKGROUND

• Pendleton 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.

  PMID: 7174838 BACKGROUND

• Ardila A, Pineda D, Rosselli M. Correlation between intelligence test scores and executive function measures. Arch Clin Neuropsychol. 2000 Jan;15(1):31-6.

  PMID: 14590565 BACKGROUND

• Norrman 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.

  PMID: 19220772 BACKGROUND

• International Study of Asthma and Allergies in Childhood Phase II Modules. (1998, May). Retrieved October 10, 2017, from International Study of Asthma and Allergies in Childhood Phase II Modules

  BACKGROUND

• Downie SR, Andersson M, Rimmer J, Leuppi JD, Xuan W, Akerlund A, Peat JK, Salome CM. Symptoms of persistent allergic rhinitis during a full calendar year in house dust mite-sensitive subjects. Allergy. 2004 Apr;59(4):406-14. doi: 10.1111/j.1398-9995.2003.00420.x.

  PMID: 15005764 BACKGROUND

• Adachi, Y., MD, PHD, Yoshida, K., MD, & Itazawa, T., MD. (n.d.). Relationship Between ARIA and ISAAC Questionnaires Regarding to the Classification and Severity of Rhinitis in School Children [Abstract]. Journal of Allergy and Clinical Immunology, 131(2), AB113. Retrieved October 10, 2017, from http://www.jacionline.org/article/S0091-6749(12)03075-8/pdf

  BACKGROUND

• Goldstein H 1995 Multilevel statistical models. In: Goldstein H, ed. Kendalls library of statistics 3. London: Edward Arnold; 87-94

  BACKGROUND

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Michael Chi Fai CF Tong, MD, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Calvin Pok Hong PH LAM, MSSc,MA,BSSc

CONTACT

852-35053395; calvinlam@link.cuhk.edu.hk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman

Study Record Dates

• First Submitted: September 22, 2018
• First Posted: October 22, 2018
• Study Start: December 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 26, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)