Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000606381p
Ethics application status
Not yet submitted
Date submitted
23/04/2017
Date registered
28/04/2017
Date last updated
28/04/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The Eastern Australian Sleep and Health Livingness Study: A Five-Year Study of the Effects of Impaired Sleep, Chronic Bodily Symptom(s) and Emotional Well-Being in Adults Living in Rural and Urban Australia Who Use Medical and/or Complementary Treatments
Scientific title
The Eastern Australian Sleep and Health Livingness Study: A Five-Year Epidemiological Study of Prognostic Clinical Predictors and Interrelationship between Impaired Sleep, Chronic Bodily Symptom(s) and Emotional Well-Being in Adults Living in Rural and Urban Australia Who Use Medical and/or Complementary Treatments
Secondary ID [1] 291754 0
Nil
Universal Trial Number (UTN)
U1111-1195-8409
Trial acronym
The EASHL Study
Linked study record
Not applicable.

Health condition
Health condition(s) or problem(s) studied:
Impaired sleep 302974 0
Chronic body pain 302975 0
Anxiety 302976 0
Depression 302977 0
Noncommunicable diseases (NCD) 302978 0
Condition category
Condition code
Respiratory 302442 302442 0 0
Other respiratory disorders / diseases
Mental Health 302443 302443 0 0
Studies of normal psychology, cognitive function and behaviour
Public Health 302444 302444 0 0
Epidemiology

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The primary aim of the study is to describe and quantify the multi-faceted inter-relationship between a diverse manifestation of impaired sleep and individual variations in physical activity, daytime cognitive function, emotional well-being and other lifestyle characteristics following 'adjunctive' treatments for sleep quality and sleep rhythm maintenance. For the study's purpose, ‘adjunctive’ treatments refer to a broad range of environmental modification, physical activity, sedatives, exogenous hormonal replacements, dietary supplements and/or emerging trend of adjunctive Complementary Medicine modalities in addition to conventional medical treatments.

The study is a prospective multi-centre community-based survey of selected Eastern Australian rural and urban centres using stratified sampling to implement matched case-control study over a period of five-years. The ‘source’ population includes the major rural centres of the Northern NSW (inclusive of Lismore and its outlying districts such as Byron Bay, Lennox Head and Ballina), the Central East Coast NSW (inclusive of Grafton and Maclean), and the urban centres of metropolitan Brisbane and Sydney.

Participants will be enrolled over a period of two years then stratified according to impaired sleep with or without chronic bodily symptom(s) and studied via confidential de-identified questionnaire-based survey supplemented by physician assessment of general health and phone interviews over a five-year period. Each participant will be assessed for their exposure to risk factors of impaired sleep with or without chronic bodily symptom(s), pattern of health care utilisation, pattern and quality of sleep, persistence and/or development of bodily symptom(s) such as pain, tiredness and fatigability in addition to task-specific cognitive impairment and emotional well-being at 0, 12, 24, 36, 48 and 60 months of the study participation.

At each data collection period, specific case report forms (CRF) will be completed and data recorded for statistical analysis. These include demographics and medical history review, measurement of blood pressure, weight, height and lung function including gas transfer DLCO using the gasless MiniBox system, assessment of current cognitive ability including Clock-Drawing Test (CDT), Sleep Timing Questionnaire (STQ), ESS (Epworth Sleepiness Score), ISI (Insomnia Severity Index), Pittsburgh Sleep Quality Index (PSQI) Questionnaire, Short form McGill Pain Score (SF-MPQ), Short form SF-12 Questionnaire (SF-12), Generalised Anxiety Depression (GAD7), State-Anxiety Inventory (STAI) and narrative description of self-reported symptoms of impaired sleep and well-being.

Participants are free to participate and/or withdraw at any time of the study. There will be no adverse effect on the quality of their medical care whether they are actively participating in the research study. The study participation is completely voluntary and no payments will be made to the participants. There is a negligible risk to participate in the research study as there is no intervention involving any additional medication, counselling or adjunctive medical therapy. All relevant clinical information is de-identified to protect confidentiality and privacy then securely stored for population-based statistical analysis.

Intervention code [1] 297867 0
Not applicable
Comparator / control treatment
Participants living in rural centres will be stratified and matched on a case-control basis to participants living in urban centres.
Control group
Active

Outcomes
Primary outcome [1] 301850 0
Prevalence rates which are calculated from the number of cases affected by impaired sleep with or without chronic bodily symptom(s) divided by the total population size of the study (i.e. up to 1,000 participants).

For the study's purpose, 'impaired sleep’ with or without chronic bodily symptom(s) is defined by a combination of the following defined criteria:
1. ESS >11 for excessive sleepiness,
2. Changes in PSQI >5 for worse sleep quality,
3. ISI score >14 for subclinical insomnia,
4. Irregular, inconsistent and/or abnormal changes in STQ parameters: total sleep time (TST), sleep onset, sleep latency periods, sleep duration and sleep fragmentation.
5. Persistent symptom(s) of greater 6 months in duration as per the qualitative pain descriptors on SF-MPQ with VAS score of at least 5 to describe intensity and extent of bodily pain(s),
6. Deteriorating changes in the selected quality of life domains of SF-12,
7. GAD7 score >7 for probable anxiety disorder,
8. Declining changes in the selected domains of the STAI.
Timepoint [1] 301850 0
0, 12, 24, 36, 48 and 60 months
Primary outcome [2] 301851 0
Cumulative incidences which are calculated from the number of new incident cases of impaired sleep with or without chronic bodily symptom(s) divided by the total number of participants ‘at risk’ for impaired sleep with or without chronic bodily symptom(s).

For the study's purpose, ‘new incident case’ is defined as those participants who do not initially meet the defined criteria of impaired sleep with or without chronic bodily symptom(s) at the time of study enrolment but subsequently develop impaired sleep with or without chronic bodily symptom(s) during the five-year timeframe of the study.

The identified ‘at risk’ population within the study is defined by borderline scores in standardised measurement tools and/or qualitative abnormalities in the narrative analysis of self-reported symptom(s) of overall well-being for impaired sleep with or without chronic bodily symptom(s) as defined previously in Primary Outcome (1).

'Chronic bodily symptom(s)' is defined as either localised or generalised non-malignant bodily symptom(s) including pain which is three months’ or greater duration as per the definition of 'chronicity' by the US National Center for Health Statistics and the Australian Institute of Health and Welfare in absence of pre-existing acute musculoskeletal trauma, post-surgical pain, phantom limb pain, and/or confirmed diagnosis of primary autoimmune disease such as multiple sclerosis (MS), systemic lupus erythematosus (SLE) or fibromyalgia.
Timepoint [2] 301851 0
0, 12, 24, 36, 48 and 60 months
Secondary outcome [1] 334172 0
Prevalence rates which are calculated from the number of cases of impaired sleep with or without cognitive impairment divided by the total population size of the study (i.e. up to 1,000 participants).

For the study’s purpose, ‘impaired cognitive function’ is defined as declining changes in the qualitative report of the participant’s narrative symptoms of overall well-being supplemented by changes in interviewer’s assessment of a significant decline in global cognitive ability and CDT score of less than 11 with or without abnormalities in SF-12 and selected domains of the STAI.
Timepoint [1] 334172 0
0, 12, 24, 36, 48 and 60 months
Secondary outcome [2] 334173 0
Cumulative incidences which are calculated from the number of new incident cases of impaired sleep with or without cognitive impairment divided by the total number of participants ‘at risk’ for impaired sleep with or without cognitive impairment.

For the study's purpose, ‘new incident case’ is defined as those participants who initially meets the criteria for normal cognitive function at the time of study enrolment but subsequently develop impaired cognitive function during the timeframe of the study as defined in Secondary Outcome (1).

The identified ‘at risk’ population within the study for global and task-specific cognitive impairment is defined by risk factors for cognitive impairment (such as age of greater than 65 years, positive family history, personal exposure to head injury, cerebrovascular event, hypertension or diabetes and alcohol and/or illicit consumption) and/or participant report of General Practitioner and/or Specialist diagnosis of a possible cognitive impairment at the time of study enrolment.
Timepoint [2] 334173 0
0, 12, 24, 36, 48 and 60 months.
Secondary outcome [3] 334174 0
Prevalence rates of pre-existing diagnosis of NCD(s) which are calculated from the number of pre-existing cases with NCD(s) divided by the total population size of the study (i.e. up to 1,000 participants).

Non-communicable disease (NCDs) is also known as chronic diseases which is greater than six months duration, of a long disease latency, of a protracted clinical course with multifactorial etiology which is of a combination of genetic, physiological, environmental and behavioral factors and no cure as per the diagnostic criteria of biomedical disease classification. NCDs include chronic respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD) and/or lung cancer, diabetes, obstructive sleep apnoea (OSA), coronary artery disease (CAD), cerebrovascular event, hypertension, hyperlipidemia, renal impairment or impaired lung function (defined as FEV1 <75% predicted with or without adjusted gas transfer DLCO of less than 75%).
Timepoint [3] 334174 0
0, 12, 24, 36, 48 and 60 months
Secondary outcome [4] 334175 0
Cumulative incidence rates of new medical diagnosis of NCD(s) which are calculated from the number of new incident cases of NCD(s) divided by the total number of participants ‘at risk’ for NCD(s) as defined in Secondary Outcome (3).

For the study's purpose, a ‘new incident case' of NCD is defined as those participants who do not have a specific medical diagnosis of NCD at the time of study enrolment but subsequently develop NCD during the five-year timeframe of the study.

The identified ‘at risk’ population within the study for NCD(s) is defined by risk factors for NCD(s) and/or participant report of a possible General Practitioner and/or Specialist diagnosis of NCD(s) at the time of study enrolment.
Timepoint [4] 334175 0
0, 12, 24, 36, 48 and 60 months
Secondary outcome [5] 334176 0
Prevalence rates of medication use are calculated from the number of cases with medication use for impaired sleep with or without chronic bodily symptom(s) divided by the total population size of the study (i.e. up to 1,000 participants). Medication use include either non-prescription formulation such as over-the-counter (OTC) drugs, diverse range of dietary supplements and/or prescription administered under General Practitioner and/or Specialist care at the time of study enrolment.
Timepoint [5] 334176 0
0, 12, 24, 36, 48 and 60 months.
Secondary outcome [6] 334177 0
Cumulative incidence rates of medication use are calculated from the number of new incident cases of medication use for impaired sleep with or without chronic bodily symptom(s) divided by the total number of participants ‘at risk’ for medication use in impaired sleep with or without chronic bodily symptom(s).

For the study's purpose, ‘new incident case' of medication use for impaired sleep with or without chronic bodily symptoms is defined as those participants who do not use any specific medication for impaired sleep with or without chronic bodily symptom(s) at the time of study enrolment but subsequently use such medication for symptomatic relief during the five-year timeframe of the study.

The identified ‘at risk’ population within the study for the specific medication use is defined by presence of impaired sleep with or without chronic bodily symptom(s) and participant report of intent to use either non-prescription formulation such as over-the-counter (OTC) drugs, diverse range of dietary supplements and/or prescription administered under General Practitioner and/or Specialist care at the time of study enrolment.

Timepoint [6] 334177 0
0, 12, 24, 36, 48 and 60 months.
Secondary outcome [7] 334180 0
Prevalence rates in the utilisation of Complementary Medicine modalities for impaired sleep with or without chronic bodily symptom(s) are calculated from the number of cases with utilisation of Complementary Medicine modalities divided by the total population size of the study (i.e. up to 1,000 participants).

For the study's purpose, 'Complementary Medicine' modalities is defined as a wide variety of non-mainstream health care practices that may be used along with conventional medical treatments. They may be classified as traditional (such as acupuncture, homeopathy or naturopathy) or innovative modalities (such as superficial or deep tissue needling or connective tissue therapy).
Timepoint [7] 334180 0
0, 12, 24, 36, 48 and 60 months.
Secondary outcome [8] 334181 0
Cumulative incidence rates in the use of Complementary Medicine modalities are calculated from the number of new incident cases who use Complementary Medicine modalities divided by the total number of participants ‘at risk’ for the use of Complementary Medicine modalities.

For the study's purpose, ‘new incident case' for the use of Complementary Medicine modalities for impaired sleep with or without chronic bodily symptom(s) is defined as those participants who do not use Complementary Medicine modalities at the time of study enrolment but subsequently report of their use during the five-year timeframe of the study.

The identified ‘at risk’ population within the study for the use of Complementary Medicine modalities is defined by risk factors for the use of Complementary Medicine modalities (such as past personal use and/or exposure within their family or social network) and/or participant report of intent to use Complementary Medicine modalities at the time of study enrolment.
Timepoint [8] 334181 0
0, 12, 24, 36, 48 and 60 months.

Eligibility
Key inclusion criteria
1. Adults aged 18 to 80 years of both genders,
2. Able to give informed verbal and written consent,
3. Self-reported symptoms of impaired or disturbed quality and/or duration of sleep,
4. Time availability for questionnaire-based survey completion over a five year period of the study on annual basis,
5. Required to have a sufficient level of education to complete questionnaire-based survey and communicate with research personnel,
6. May or may not have one or more chronic disease(s),
7. May or may not have a prior diagnosis and treatment of sleep-disordered breathing (SDB) including narcolepsy and obstructive sleep apnoea (OSA) with continuous positive airway pressure (CPAP), mandibular advancement splint (MAS) or previous history of upper laryngeal surgery such as UPPP (uvulopalatopharyngoplasty),
8. Either previously used or currently using any form of ‘adjunctive’ treatment for impaired sleep with or without chronic bodily symptom(s) such as environmental modification, physical activity, sedatives, exogenous hormonal replacements, dietary supplements and/or emerging trend of adjunctive Complementary Medicine modalities in addition to conventional medical treatments.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Inability or unwillingness to give written informed verbal and written consent,
2. Participation in a study of an investigational medication within the past 30 days,
3. Participation in a current study of an investigational sleep intervention,
4. Active psychiatric disease under maintenance medical treatment (inclusive of bipolar affective disease, unstable clinical depression, psychoses and post-traumatic stress disorder),
5. Current terminal illness due to advanced organ failure and/or cancer,
6. Current or previous medical patient of the Principal Investigator.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Sample size calculation and statistical assumptions:
The estimated prevalence of insomnia is between 13 to 33% of the adult population in Australia, although actual prevalence would be higher given the current epidemiological trend in increasing body adiposity, advanced age and chronic diseases. By contrast, chronic bodily pain (CBP) affects up to one in five adults and a higher prevalence of one in third for those aged 65 or greater. The estimated prevalence of insomnia or excessive sleepiness associated with CBP and/or chronic disease is yet undefined in regional Australia.

Relevant to the exposure to ‘adjunctive’ treatment to impaired sleep with or without chronic bodily symptom(s) is ill-defined in the published literature. However, it is estimated that up to 85% of primary care population have either used or using some form of Complementary Medicine modalities for a broad range of health issues. Therefore, the possibility of selection bias from disproportionately low prevalence of exposure to ‘adjunctive’ treatment is negligible for the study.

Given the published prevalence of insomnia or sleepiness and CBP in the unexposed group of 33% and a lower minimum prevalence in the exposed of 13% with ratio of sample size in unexposed to exposed of 1, the minimum sample size needed for each group to demonstrate statistically significant differences between the exposed versus unexposed group ranges from 68 (Fleiss) to 77 (Fleiss with continuity correction) individuals per group. This assumes the confidence interval at 0.05, power of 0.80 and a minimum odds ratio of 0.3. If a greater odds ratio of 2 or more is expected, then each group sample size will range from 137 (Fleiss) to 149 (Fleiss with continuity correction).

For the prospective population-based study, a representative sample up to 1,000 people will be interviewed and studied over a five-year period: 200 participants from the Lismore Health Services District, 200 participants from the Clarence Valley Health Services District, 200 participants from metropolitan Sydney, 200 participants from metropolitan Brisbane, and 200 participants from the Northern Rivers-Brisbane-Sydney study base population with regular exposure to ‘adjunctive’ treatment for impaired sleep and/or chronic bodily symptom(s). The recruitment of study participants will adjust for the potential loss of follow up with a response rate of at least 85% which is a reasonable estimated rate of a dedicated community-based survey using stratified sampling methodology. Potential loss of follow up is minimised through direct face-to-face interview with informed consent, simplified questionnaire design and phone follow up. Non-responders will be analysed to outline the differences between responders and non-responders within the study duration.

Overview of Statistical Analysis:
Descriptive statistics will summarise the quantitative descriptions of the study population for the longitudinal observational cohort study. Univariate analysis will examine each of the important symptom variables of pain, sleep and physiological sleep data for the observed differences in the distribution, central tendency and dispersion. Descriptive statistics will summarise the quantitative descriptions of the study population according to the predictors of interest (POI) in the group of individuals exposed to diverse treatment modalities versus those individuals unexposed to diverse treatment modalities.

Confounding variables include the effect of age, gender and medical comorbidity, which are adjusted in participant stratification at the commencement of the study. Accordingly, group matching and analysis according to age, gender and exposure to ‘adjunctive’ treatment will be performed to minimise the effects of confounding. In addition to identifying predictors of clinically important outcomes, estimated case prevalence, disease interrelationships and adjusted odds ratio will be calculated using the traditional case-control study design technique. Herein, the ‘prevalent case’ refers to those participants who are exposed to either medical treatments alone or ‘adjunctive’ treatment in addition to medical treatment for impaired sleep with or without chronic bodily symptom(s).

It is possible that either of the exposed or unexposed group to ‘adjunctive’ treatments for impaired sleep with or without chronic bodily symptom(s) will ‘cross-over’ to another group over the five-year period of the prospective population study. Based on the two-group post-test randomised experimental model, the measured differences between the means of the specific measured outcomes will be analysed via unpaired T-test or one-way ANOVA assuming the two crossover treatment sequences with a two-sided significance level (1-alpha) of 95%, power (1-beta, % chance of detecting) of 80%, a minimum drop-out threshold rate of 10%, 1:1 ratio of sample size between unexposed and exposed, percentage of unexposed with outcome at 5% and percentage of exposed with outcome at 33%.

Inferential statistics will be utilised to derive objective conclusion of the entire study population using multivariate analysis and general linear model: t-test, analysis of variance (ANOVA), analysis of covariance (ANCOVA), and weighted Cox proportional hazards regression model. Multivariate analysis using unpaired logistic regression will be used if a specific subgroup is matched, or paired logistic regression if the subgroup is unmatched according to age, gender and exposure to ‘adjunctive’ treatment. The ‘true effect’ size (t-value) will be calculated for the study population from the ratio of the differences between the group means and the variability of groups and applied to inferential statistics.




Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2017
Actual
Date of last participant enrolment
Anticipated
30/06/2019
Actual
Date of last data collection
Anticipated
30/06/2024
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment postcode(s) [1] 15829 0
4000 - Brisbane
Recruitment postcode(s) [2] 15832 0
2000 - Sydney
Recruitment postcode(s) [3] 15833 0
2478 - Ballina
Recruitment postcode(s) [4] 15834 0
2480 - Lismore
Recruitment postcode(s) [5] 15835 0
2478 - Lennox Head
Recruitment postcode(s) [6] 15836 0
2481 - Byron Bay
Recruitment postcode(s) [7] 15837 0
2460 - Grafton

Funding & Sponsors
Funding source category [1] 296254 0
Commercial sector/Industry
Name [1] 296254 0
Integrative Pulmonary Care & Medical Pty Ltd
Country [1] 296254 0
Australia
Primary sponsor type
Individual
Name
Samuel Kim MBBS FRACP MPH MBA MMed (Sleep)
Address
Integrative Pulmonary Care & Medical Pty Ltd
Suite 287-288 Ground Floor
St. Andrew's Place
33 North Street
Spring Hill BRISBANE QLD 4000
Country
Australia
Secondary sponsor category [1] 295169 0
None
Name [1] 295169 0
Address [1] 295169 0
Country [1] 295169 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 297491 0
University of Queensland Ethics Committee
Ethics committee address [1] 297491 0
Ethics committee country [1] 297491 0
Australia
Date submitted for ethics approval [1] 297491 0
09/05/2017
Approval date [1] 297491 0
Ethics approval number [1] 297491 0

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

Contacts
Principal investigator
Name 67442 0
Dr Samuel Kim MBBS FRACP MPH MBA MMed (Sleep)
Address 67442 0
Integrative Pulmonary Care & Medical Pty Ltd
Suite 287-288 Ground Floor
St. Andrew's Place
33 North Street
SPRING HILL BRISBANE QLD 4000
Country 67442 0
Australia
Phone 67442 0
61738391863
Fax 67442 0
61738391864
Email 67442 0
sam@pulmonarycare.com.au
Contact person for public queries
Name 67443 0
Samuel Kim MBBS FRACP MPH MBA MMED (Sleep)
Address 67443 0
Integrative Pulmonary Care & Medical Pty Ltd
Suite 287-288 Ground Floor
St. Andrew's Place
33 North Street
SPRING HILL BRISBANE QLD 4000
Country 67443 0
Australia
Phone 67443 0
61738391863
Fax 67443 0
61738391864
Email 67443 0
sam@pulmonarycare.com.au
Contact person for scientific queries
Name 67444 0
Samuel Kim MBBS FRACP MPH MBA MMed (Sleep)
Address 67444 0
Integrative Pulmonary Care & Medical Pty Ltd
Suite 287-288 Ground Floor
St. Andrew's Place
33 North Street
SPRING HILL BRISBANE QLD 4000
Country 67444 0
Australia
Phone 67444 0
61738391863
Fax 67444 0
61738391864
Email 67444 0
sam@pulmonarycare.com.au

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No Supporting Document Provided



Results publications and other study-related documents

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