Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000861853
Ethics application status
Approved
Date submitted
24/08/2020
Date registered
5/07/2021
Date last updated
13/07/2022
Date data sharing statement initially provided
5/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
The mechanism of Continuous Positive Airway Pressure (CPAP) on hearing function in Obstructive Sleep Apnea (OSA) patients
Scientific title
The mechanism of Continuous Positive Airway Pressure (CPAP) on hearing function in Obstructive Sleep Apnea (OSA) patients
Secondary ID [1] 300911 0
Nil known
Universal Trial Number (UTN)
U1111-1257-3361
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obstructive Sleep Apnea 318731 0
Hearing Loss 318732 0
Condition category
Condition code
Respiratory 316746 316746 0 0
Sleep apnoea
Ear 316747 316747 0 0
Other ear disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Three participant cohorts will be enrolled:
- Suspected OSA participants
- Healthy Volunteers without CPAP
- Non-OSA participants with Eustachian tube disorder

What is involved:
Suspected OSA participants:
Part 1: Overnight Sleep Study
-a battery of audiological assessment prior to sleep in the overnight sleep laboratory. This will be pure-tone audiometry, tympanometry, acoustic reflexes, otoacoustic emissions and subjective surveys on hearing and balance (12-item Spatial and Qualities of Hearing Scale (SSQ12); Hearing Handicap Inventory for Adults - Screening (HHIA-S) for participants under the age of 65 or Hearing Handicap Inventory for Elderly (HHIE-S) for participants over the age of 65; Dizziness Handicap Inventory (DHI); 4-item vestibular screening tool. This will be approximately 40 minutes - 1 hour in duration
- During sleep, tympanometry will be completed approximately every 2 hours of sleep. If participants are prescribed CPAP therapy, tympanometry will be completed during sleep with CPAP approximately every 2-4 cmH20 CPAP increase. Participants with moderate OSA (AHI 15-30 events/hour) or severe OSA (AHI 31+ events/hour) are normally prescribed CPAP by the sleep physiologist. The overall sleep study will be approximately 10 hours including set up and 8 hours of sleep.
- In the morning, the battery of audiological assessments will be completed. This will be pure-tone audiometry, tympanometry, acoustic reflexes, otoacoustic emissions. This will be approximately 30 minutes in duration.
- An additional 40 minute audiological assessments will be untaken at 30-day follow up for participants who were issued CPAP. These would be the same assessments completed before sleep at baseline.

Part 2: Daytime Eustachian Tube Evaluation:
- Additional Eustachian Tube Evaluation- Up to 20 diagnosed severe OSA patients (AHI 31+ events/hour) recruited above will be asked to come to the University of Auckland Hearing and Tinnitus Clinic to complete Eustachian tube evaluation. This will involve pure-tone audiometry, tympanometry, Eustachian Tube function testing, acoustic reflexes, otoacoustic emissions and subjective surveys on hearing (12-item Spatial and Qualities of Hearing Scale (SSQ12)). CPAP will be applied while the patient is awake. Tympanometry, Eustachian tube function testing and video otoscopy (if available) will be repeated at CPAP pressure of 4cmH20, 10cmH20, 16cmH20 and 20cmH20. After CPAP, tympanometry, Eustachian tube function testing and acoustic reflexes will be repeated. This will take approximately 1 - 1 1/2 hours in duration during the day. As these patients would have been using CPAP therapy for awhile, up to 20 suspected OSA participants with high probability of severe (based from their sleep specialist assessment from the clinic letter) will also complete this Eustachian tube evaluation
This visit can occur anytime after Part 1 at a convenient time for the participants.


Healthy Participants:
Part 1: Overnight Sleep Study
-a battery of audiological assessment prior to sleep in the sleep laboratory. This will be pure-tone audiometry, tympanometry, acoustic reflexes, otoacoustic emissions and subjective surveys on hearing and balance (12-item Spatial and Qualities of Hearing Scale (SSQ12); Hearing Handicap Inventory for Adults - Screening (HHIA-S) for participants under the age of 65 or Hearing Handicap Inventory for Elderly (HHIE-S) for participants over the age of 65; Dizziness Handicap Inventory (DHI); 4-item vestibular screening tool. This will be approximately 40 minutes - 1 hour in duration
- During sleep, tympanometry will be completed approximately every 2 hours of sleep. The overall sleep study will be approximately 10 hours including set up and 8 hours of sleep.
- In the morning, the battery of audiological assessments will be completed. This will be pure-tone audiometry, tympanometry, acoustic reflexes, otoacoustic emissions. This will be approximately 30 minutes in duration.

Part 2: Daytime Eustachian Tube Evaluation:
- Additional Eustachian Tube Evaluation- Up to 20 healthy participants recruited above will be asked to come to the University of Auckland Hearing and Tinnitus Clinic to complete Eustachian tube evaluation. This will involve pure-tone audiometry, tympanometry, Eustachian Tube function testing, acoustic reflexes, otoacoustic emissions and subjective surveys on hearing (12-item Spatial and Qualities of Hearing Scale (SSQ12)). CPAP will be applied while the patient is awake. Tympanometry, Eustachian tube function testing and video otoscopy (if available) will be repeated at CPAP pressure of 4cmH20, 10cmH20, 16cmH20 and 20cmH20. After CPAP, tympanometry, Eustachian tube function testing and acoustic reflexes will be repeated. This will take approximately 1 - 1 1/2 hours in duration during the day.
This visit can occur anytime after Part 1 at a convenient time for the participants.

Non-OSA participants with Eustachian Tube Disorder:
Part 1: Overnight Sleep Study
- Not completed by this participant group

Part 2: Daytime Eustachian Tube Evaluation:
- Eustachian Tube Evaluation- Up to 20 Non-OSA participants with Eustachian tube disorder will be asked to come to the University of Auckland Hearing and Tinnitus Clinic to complete Eustachian tube evaluation. This will involve pure-tone audiometry, tympanometry, Eustachian Tube function testing, acoustic reflexes, otoacoustic emissions and subjective surveys on hearing (12-item Spatial and Qualities of Hearing Scale (SSQ12)). CPAP will be applied while the patient is awake. Tympanometry, Eustachian tube function testing and video otoscopy (if available) will be repeated at CPAP pressure of 4cmH20, 10cmH20, 16cmH20 and 20cmH20. After CPAP, tympanometry, Eustachian tube function testing and acoustic reflexes will be repeated. This will take approximately 1 - 1 1/2 hours in duration during the day.
This visit can occur anytime after Part 1 at a convenient time for the participants.




Intervention code [1] 318407 0
Diagnosis / Prognosis
Comparator / control treatment
During the overnight sleep study, suspected OSA patients will be diagnosed. No OSA is classified as AHI < 5 events/hour. Mild OSA is AHI 5-14 events/hour. Moderate OSA is AHI of 15-30 events/hour. Severe OSA is 31+ events/hour.

Healthy volunteers will also undergo overnight sleep study to make sure their AHI is < 5events/hour. Healthy volunteers and patients who end up not being diagnosed with OSA are the controls.
Control group
Active

Outcomes
Primary outcome [1] 324876 0
Middle Ear Function through Tympanometry
Timepoint [1] 324876 0
Part 1: Overnight Sleep Study
- Baseline
- approximately every 2 hours during a 8 hour sleep study without CPAP
- every 2-4cmH20 increase during CPAP during sleep (if applicable)
- post-sleep study in the morning
- 30 day follow up (CPAP patients only)

Part 2: Daytime Eustachian Tube Evaluation:
- Baseline
- during CPAP at pressure 4, 10, 16, 20cmH20. Total CPAP use will be only up to 1 hour during the day
- immediately post CPAP testing
Primary outcome [2] 324877 0
Middle ear function through acoustic reflexes
Timepoint [2] 324877 0
Part 1: Overnight Sleep Study
- Baseline
- post-sleep study in the morning
- 30 day follow up (CPAP patients only)

Part 2: Daytime Eustachian Tube Evaluation:
- Baseline
- immediately post CPAP testing
Secondary outcome [1] 386062 0
Hearing thresholds through diagnostic audiometer
Timepoint [1] 386062 0
Part 1: Overnight Sleep Study
- Baseline
- post-sleep study in the morning
- 30 day follow up (CPAP patients only)

Part 2: Daytime Eustachian Tube Evaluation:
- Baseline
Secondary outcome [2] 386063 0
Inner ear function through Otoacoustic Emissions
Timepoint [2] 386063 0
Part 1: Overnight Sleep Study
- Baseline
- post-sleep study in the morning
- 30 day follow up (CPAP patients only)

Part 2: Daytime Eustachian Tube Evaluation:
- Baseline
Secondary outcome [3] 386064 0
Subjective Surveys on Hearing through 12-item Spatial and Qualities of Hearing Scale (SSQ12)
Timepoint [3] 386064 0
Part 1: Overnight Sleep Study
- Baseline
- 30 day follow up (CPAP patients only)

Part 2: Daytime Eustachian Tube Evaluation:
- Baseline
Secondary outcome [4] 386065 0
- Subjective Surveys on Hearing through Hearing Handicap Inventory For Adults - Screening (HHIA-S) - used on patient under the age of 65.
- Subjective Surveys on Hearing Handicap Inventory for Elderly - Screening (HHIE-S) - used on patient aged 65 and older.
Timepoint [4] 386065 0
Part 1: Overnight Sleep Study
- Baseline
- 30 day follow up (CPAP patients only)
Secondary outcome [5] 386066 0
Subjective Surveys on Balance through Dizziness Handicap Inventory (DHI) survey
Timepoint [5] 386066 0
Part 1: Overnight Sleep Study
- Baseline
- 30 day follow up (CPAP patients only)
Secondary outcome [6] 386067 0
Subjective Surveys on Balance through 4-item Vestibular Screening Tool
Timepoint [6] 386067 0
Part 1: Overnight Sleep Study
- Baseline
- 30 day follow up (CPAP patients only)
Secondary outcome [7] 396853 0
Eustachian Tube Function
Timepoint [7] 396853 0
Part 2: Daytime Eustachian Tube Evaluation:
- Baseline
- during CPAP at pressure 4, 10, 16, 20cmH20. Total CPAP use will be only up to 1 hour during the day
- immediately post CPAP testing

Eligibility
Key inclusion criteria
Suspected OSA Patients
- 18 years and over
- Suspected of OSA scheduled for an overnight sleep study

Healthy Volunteers
-18 years and over

Non-OSA with Eustachian Tube Disorder:
-18 years and over
-Current diagnosis of Eustachian Tube Disorder (with Type C Tympanograms)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Suspected OSA Patients
- Previously used CPAP or currently using CPAP
- Contraindicated to use CPAP
- People who are pregnant or think they may be pregnant

Healthy Volunteers
- Previously diagnosed with OSA
-Previously diagnosed with middle ear disorder within the last year or current middle ear disorder
- Contraindicated to use CPAP
- People who are pregnant or think they may be pregnant

Non-OSA with Eustachian Tube Disorder
- Previously diagnosed with OSA
- Contraindicated to use CPAP
- People who are pregnant or think they may be pregnant

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
A total of 110 participants will be recruited with 22 participants per group (groups: mild OSA, moderate OSA, severe OSA, non-OSA with Eustachian tube disorder and healthy volunteers). This was chosen based upon a binomial model of 90% confidence and 90% reliability Since the severity of OSA will be unknown until they have completed the overnight sleep study, it is estimated that an additional 40 participants might be required to reach the minimum of 22 participant per OSA severity groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
7/05/2019
Date of last participant enrolment
Anticipated
30/09/2021
Actual
8/08/2021
Date of last data collection
Anticipated
30/09/2021
Actual
8/08/2021
Sample size
Target
150
Accrual to date
Final
92
Recruitment outside Australia
Country [1] 22871 0
New Zealand
State/province [1] 22871 0
Auckland

Funding & Sponsors
Funding source category [1] 305358 0
University
Name [1] 305358 0
The Eisdell Moore Centre Student Grant
Country [1] 305358 0
New Zealand
Funding source category [2] 306530 0
University
Name [2] 306530 0
University of Auckland Postgraduate Research Student Stipend (PReSS)
Country [2] 306530 0
New Zealand
Funding source category [3] 306531 0
Other Collaborative groups
Name [3] 306531 0
Callaghan Student Fellowship Grant
Country [3] 306531 0
New Zealand
Funding source category [4] 311824 0
Other Collaborative groups
Name [4] 311824 0
NZSAS Trust
Country [4] 311824 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Research Office, Level 10, Building 620, 49-51 Symonds Street, Auckland, 1010
Country
New Zealand
Secondary sponsor category [1] 307059 0
None
Name [1] 307059 0
Address [1] 307059 0
Country [1] 307059 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305691 0
Northern B Health and Disability Ethics Committees
Ethics committee address [1] 305691 0
Ethics committee country [1] 305691 0
New Zealand
Date submitted for ethics approval [1] 305691 0
20/02/2019
Approval date [1] 305691 0
15/03/2019
Ethics approval number [1] 305691 0
19/NTB/29

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101242 0
Ms Irene Cheung
Address 101242 0
Level 3, Building 507
School of Population Health
University of Auckland Grafton Campus
22-30 Park Ave
Grafton
Auckland, 1023
Country 101242 0
New Zealand
Phone 101242 0
+64 211879607
Fax 101242 0
Email 101242 0
[email protected]
Contact person for public queries
Name 101243 0
Irene Cheung
Address 101243 0
Level 3, Building 507
School of Population Health
University of Auckland Grafton Campus
22-30 Park Ave
Grafton
Auckland, 1023
Country 101243 0
New Zealand
Phone 101243 0
+64 211879607
Fax 101243 0
Email 101243 0
[email protected]
Contact person for scientific queries
Name 101244 0
Irene Cheung
Address 101244 0
Level 3, Building 507
School of Population Health
University of Auckland Grafton Campus
22-30 Park Ave
Grafton
Auckland, 1023
Country 101244 0
New Zealand
Phone 101244 0
+64 211879607
Fax 101244 0
Email 101244 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.