Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00534

2 Trial Registration Date

2016-11-21

iRegistration Status

Prospective

3 Secondary IDs

-

4 Source(s) of Funding

Department of Otorhinolaryngology, Head and Neck Surgery, CUHK

5 Primary Sponsor

Prof Michael Chi Fai Tong

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

7Responsible Contact Person (public contact person for patients interested in participating)

i Name

Janice Lin

ii Address

Department of Otorhinolaryngology, Head and Neck Surgery,
6/F Lui Che Woo Clinical Sciences Building,
Prince of Wales Hospital

iii Phone

3505 2628

iv Email

janicelin@ent.cuhk.edu.hk

v Affiliation

Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

vi Country

Hong Kong

8Research Contact Person (person to contact for scientific inquiries)

i Name

Michael Tong

ii Address

Department of Otorhinolaryngology, Head and Neck Surgery,
6/F Lui Che Woo Clinical Sciences Building,
Prince of Wales Hospital

iii Phone

35052628

iv Email

mtong@ent.cuhk.edu.hk

v Affiliation

Department of Otorhinolaryngology, Head and Neck Surgery, The Chinese University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Study to investigate the correlation between Peak Nasal Inspiratory Flow with sleep-related symptoms in Allergic Rhinitis

10 Public Title

Study to investigate the correlation between Peak Nasal Inspiratory Flow with sleep-related symptoms in Allergic Rhinitis

i Public Title in Chinese 研究名稱

鼻敏感患者的鼻尖峰吸氣流量與睡眠質素之關係

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-10-27

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.562

14 Medical Condition Being Studied

Allergic rhinitis

15Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

Peak Nasal Inspiratory Flow meter

iii Dosage form of the intervention

-

iv Dosage of the intervention

-

v Duration of the intervention

-

vi Frequency of the intervention

-

16Comparative Treatments

i Description/ name of comparative treatments

N/A

ii Dosage form of the comparative treatments

-

iii Dosage of the comparative treatments

-

iv Duration of the comparative treatments

-

v Frequency of the comparative treatments

-

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1. Both genders of 18 years and over

2. Abbreviated Mental Test>=6

3. Ability to understand the nature, scope and possible consequences of the study

4. Capability and willingness to comply with the requirements of the protocol

ii Exclusion Criteria

1. 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. With prior nasal surgery eg. surgery performed in nasal cavity, sinuses

3. History of known sleep disorder, central and obstructive sleep apnoea, narcolepsy, insomnia, patients requiring regular sleep medication and those hypersensitive to applied topical nasal steroids

4. Respiratory tract infection within the past 30 days

5. Clinically major cardiovascular, respiratory, hepatic, neurological, endocrine, immunological, or other major systemic diseases

6. History of drug or alcohol abuse

7. On concurrent immunosuppressive therapy or systemic steroid treatment

8. On other medications that could affect nasal/ocular symptoms, sleep/daytime performance eg. decongestants, anti-inflammatory drugs, oral/long acting inhaled beta-agonist, sleeping pills

9. On self-prescribed rhinitis or sleep medication

10. Unable to perform PNIF by himself/herself

iii Age Minimum

18

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Observational

19Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

Pilot study

vi Study Objectives (Optional)

To determine the use of nasal peak inspiratory flow meter as an objective tool to monitor the effect of chronic rhinitis on sleep quality on a daily basis

20 Anticipated trial start date

2016-11-24

21 Target Sample Size

60

22 Recruitment Status

Recruiting

23Primary Outcome

iThe Name of the outcome

Nasal flow and patency

iiThe metric or method of measurement used

Peak inspiratory flow measurements

iiiThe timepoint(s) of primary interest

am upon awakening, noon, evening before sleep fo 7 consecutive days

24Secondary Outcome

iThe Name of the outcome

7-day sleep diary including information on sleep onset latency, total sleep time, frequency of nightly awakenings, sleep quality, mood, alertness, daytime fatigue etc.

iiThe metric or method of measurement used

7-day sleep diary

iiiThe timepoint(s) of primary interest

7 consecutive days after pre-assessment

Secondary Outcome

iThe Name of the outcome

Rhinitis condition scoring

iiThe metric or method of measurement used

Rhinitis scales and questionnaires: VAS, TNSS, SNOT-22

iiiThe timepoint(s) of primary interest

pre and post assessment

Secondary Outcome

iThe Name of the outcome

Sleep quality

iiThe metric or method of measurement used

ESS, PSQI

iiiThe timepoint(s) of primary interest

pre assessment

Secondary Outcome

iThe Name of the outcome

Objective inferior turbinate grading

iiThe metric or method of measurement used

Friedman grading

iiiThe timepoint(s) of primary interest

during endoscopy

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2022-03-17

27 Primary Registry and Trial Identifying Number

ChiCTR-ROC-16010045

28 Date of Registration in Primary Registry

2016-11-21

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Trial Detail