Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00626

2 Trial Registration Date

2018-10-08

i Registration Status

Prospective

3 Secondary IDs

CREC Ref. NO.: 2017.553

4 Source(s) of Funding

Dept. of Otorhinolaryngology, Head and Neck Surgery, CUHK

5 Primary Sponsor

Dept. of Otorhinolaryngology, Head and Neck Surgery, CUHK

6 Secondary Sponsor

N/A

Function

Not Applicable

Please specify

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

i Name

Ms. Kit Chan

ii Address

Room 84026, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

3505 1277

iv Email

kitchan@ent.cuhk.edu.hk

v Affiliation

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

vi Country

Hong Kong SAR

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

i Name

Michael Tong

ii Address

Room 84026, 6/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

iii Phone

3505 1277

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 SAR

9 Official Scientific Title of the Study

Audiological benefits and subjective satisfaction with adhesive bone-conduction device in conductive hearing loss patients

10 Public Title

Audiological benefits and subjective satisfaction with adhesive bone-conduction device in conductive hearing loss patients

i Public Title in Chinese 研究名稱

黏合式骨導助聽器對傳導性弱聽人士的聽力效益及用者滿意狀況

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong SAR

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2018-01-24

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2017.553

14 Medical Condition Being Studied

conductive hearing loss

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

An adhesive form of bone-conduction hearing device

iii Dosage form of the intervention

N/A

iv Dosage of the intervention

N/A

v Duration of the intervention

8 weeks of use during waking hours

vi Frequency of the intervention

N/A

16 Comparative Treatments

i Description/ name of comparative treatments

No comparative treatment

ii Dosage form of the comparative treatments

N/A

iii Dosage of the comparative treatments

N/A

iv Duration of the comparative treatments

N/A

v Frequency of the comparative treatments

N/A

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Unilateral or bilateral conductive hearing loss, as defined by the affected ear(s) having bone-conduction thresholds of no worse than 25 dB(HL) at 0.5 – 4 kHz and air-bone gaps of at least 10 dB at three of the tested frequencies;

Absence of skin or scalp conditions that may preclude attachment of the adhesive adapter, or interfere with audio processor usage;

Aged 6 years and above and can comply with evaluation procedures;

Cantonese as the primary language;

Willingness to attend extra audiological sessions for evaluating device benefits;

Willingness to fill out journal regarding device usage and questionnaires regarding user satisfaction;

Willingness and being able to provide daily care to a loaned device;

Gives consent to taking part in the study.

ii Exclusion Criteria

Does not meet one or more of the inclusion criteria listed above;

Any type of hearing loss other than conductive;

Health, physical, or cognitive conditions that would interfere with the completion of, participation in, or provision of valid responses during the required audiological evaluations, or interfere with adherence to study procedures.

iii Age Minimum

6 years old

iv Age Maximum

999

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

Other

Please specify

Device received FDA clearance.

vi Study Objectives (Optional)

20 Anticipated trial start date

2018-11-01

21 Target Sample Size

40

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Change in sound-field audiometric threshold

ii The metric or method of measurement used

Sound-field audiometry

iii The timepoint(s) of primary interest

Week 4, Week 8

Primary Outcome

i The Name of the outcome

Change in sentence reception threshold in noise

ii The metric or method of measurement used

Cantonese Hearing In Noise Test (CHINT)

iii The timepoint(s) of primary interest

Week 4, Week 8

Primary Outcome

i The Name of the outcome

Self-rated hearing qualities associated with device use

ii The metric or method of measurement used

Speech, Spatial and Qualities of Hearing scale (SSQ12)

iii The timepoint(s) of primary interest

Week 4, Week 8

24 Secondary Outcome

i The Name of the outcome

User experience with the adhesive bone-conduction device

ii The metric or method of measurement used

ADHEAR Use and Satisfaction Questionnaire

iii The timepoint(s) of primary interest

Week 8

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2018-12-05

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2018-10-08