Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000011381
Ethics application status
Approved
Date submitted
15/12/2016
Date registered
4/01/2017
Date last updated
11/03/2019
Date data sharing statement initially provided
11/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A field survey of windfarm and traffic noise effects on sleep
Scientific title
Identification of noise-related sleep problems, based on overnight noise exposure in wind farm-exposed, traffic noise-exposed and quiet rural areas: A field survey.
Secondary ID [1] 289539 0
GNT1113571
Universal Trial Number (UTN)
U1111-1191-1014
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Noise effects on sleep 299252 0
Condition category
Condition code
Public Health 299262 299262 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This survey will recruit participants from stratified samples of wind farm exposed and wind farm naïve participants in order to reduce bias effects. Our aim is to use the most appropriate sampling methods to draw a random sample of individuals in relevant exposure groups (within a 10 km radius of the nearest turbine in targeted areas vs control regions). We will then apply Computer-Assisted Telephone Interviews (CATI) to examine sleep and noise problem frequencies as a function of proximity to known noise sources. Telephone interviewers will cold call pre-selected individuals as many times as is needed until either survey responses are obtained from specific individuals pre-selected with a predetermined probability of selection, or multiple and repeated attempts fail to elicit a response. This approach specifically aims to obtain the least biased representation of noise impacts on exposure versus comparator populations, and has yet to be conducted in any wind farm exposed-population worldwide.
The survey will include key elements from a survey already developed and used in a Health Canada study. It will be brief and will specifically focus on sleep, with only general night-time noise questions directly relevant to sleep and proximity to noise sources within the past 3 months. To gain further insights into effects, follow-up validated questionnaires (i.e., Pittsburgh Sleep Quality Index, PSQI; Insomnia Severity Index, ISI; Epworth Sleepiness Scale, ESS) quality of life (EQ-5D) and Functional Outcomes of Sleep Questionnaire (FOSQ), will be sent via postal mail to all residents who consent to being contacted regarding further participation in the survey. Return envelopes and reminders will be used to maximise response rates.
Intervention code [1] 295134 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298743 0
The main outcome of the survey is to identify 4 groups according to overnight noise exposure type and level of complaints into; highest complaint quartiles in wind farm and traffic noise exposure groups (WFNQ1 and TNQ1), lowest quartile complaints in the wind farm exposure group (WFNQ4) and a quiet rural exposure control group (CN). Level of complaints will be generated using a combination of scores from the Pittsburgh Sleep Quality Index, (PSQI); Insomnia Severity Index, (ISI); Epworth Sleepiness Scale, (ESS); quality of life (EQ-5D) and Functional Outcomes of Sleep Questionnaire (FOSQ). In addition, responses to general night-time noise questions directly relevant to sleep and proximity to noise sources within the past 3 months will be used to identify residents who indicate high vs. low complaints.
Timepoint [1] 298743 0
Once a minimum of 400 responses to surveys are collected, or at least 200 from wind farm-exposed areas & 200 responses from wind farm-naive areas.
Secondary outcome [1] 330378 0
To describe self-reported sleep in different exposure groups using the Pittsburgh Sleep Quality Index, (PSQI); Insomnia Severity Index, (ISI); Epworth Sleepiness Scale, (ESS); quality of life (EQ-5D) and Functional Outcomes of Sleep Questionnaire (FOSQ).
Timepoint [1] 330378 0
Once a minimum of 400 responses to surveys are collected, or at least 200 from wind farm-exposed areas & 200 responses from wind farm-naive areas.
Secondary outcome [2] 330379 0
To describe overnight-noise outcomes in different exposure groups using the general night-time noise questions directly relevant to sleep and proximity to noise sources.
Timepoint [2] 330379 0
Once a minimum of 400 responses to surveys are collected, or at least 200 from wind farm-exposed areas & 200 responses from wind farm-naive areas.

Eligibility
Key inclusion criteria
1. Age: > 17 years.
2. Willing and able to complete the survey. Consent will be implied on the basis of survey completion given that separate consent is not practical for online survey tools we plan to predominantly use where possible.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Language difficulties that might preclude informed consent and study questionnaire completion.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
This survey is the first part of a larger project. It is designed to identify people who report being affected by wind farm noise and others who do not. Following data collection from survey responses, we will identify 4 groups according to overnight noise exposure type and level of complaints into:

- Highest complaint quartiles in wind farm and traffic noise exposure groups (WFNQ1 and TNQ1);
- Lowest quartile complaints in the wind farm exposure group (WFNQ4);
- Quiet rural exposure control group (CN).

These will be used to identify study groups for Part 2 (In-Home Study) or Part 3 (In-Lab Study) of the project. Using computerised minimisation/randomisation, individuals within these groups will be sequentially invited to participate in further in-home or in-laboratory measurement sleep studies.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
5/02/2018
Actual
15/05/2018
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
1/09/2020
Actual
Sample size
Target
538
Accrual to date
455
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 293914 0
Government body
Name [1] 293914 0
National Health and Medical Research Council
Country [1] 293914 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Sturt Rd
Bedford Park
South Australia 5042
Country
Australia
Secondary sponsor category [1] 292741 0
Hospital
Name [1] 292741 0
Repatriation General Hospital
Address [1] 292741 0
Adelaide Institute for Sleep Health
216 Daws Rd
Daw Park
South Australia 5041
Country [1] 292741 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295334 0
Southern Adelaide Clinical Human Research Ethics Committee (SAC HREC)
Ethics committee address [1] 295334 0
Ethics committee country [1] 295334 0
Australia
Date submitted for ethics approval [1] 295334 0
02/06/2016
Approval date [1] 295334 0
20/10/2016
Ethics approval number [1] 295334 0
HREC/16/SAC/207 55.16

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

Contacts
Principal investigator
Name 60462 0
A/Prof Peter Catcheside
Address 60462 0
Adelaide Institute for Sleep Health:
A Flinders Centre for Research Excellence
Repatriation General Hospital
Daws Rd, Daw Park
South Australia 5041
Australia
Country 60462 0
Australia
Phone 60462 0
+61 8 8275 1309
Fax 60462 0
Email 60462 0
[email protected]
Contact person for public queries
Name 60463 0
Gorica Micic
Address 60463 0
Flinders University
Sturt Rd, Bedford Park
South Australia 5042
Australia
Country 60463 0
Australia
Phone 60463 0
+61 8 8201 2377
Fax 60463 0
+61 8 8201 2388
Email 60463 0
[email protected]
Contact person for scientific queries
Name 60464 0
Peter Catcheside
Address 60464 0
Adelaide Institute for Sleep Health:
A Flinders Centre for Research Excellence
Repatriation General Hospital
Daws Rd, Daw Park
South Australia 5041
Australia
Country 60464 0
Australia
Phone 60464 0
+61 8 8275 1309
Fax 60464 0
Email 60464 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
There are ethical and logistical considerations that would prevent IPD sharing. Mechanisms to enable public data sharing for this project do not exist.


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.