None listed
Conditions
Brief summary
Increasingly recognised within the clinical disciplines of Medicine and Public Heath over the past four decades, dysfunctional sleep continues to impose incremental costs to the community due to declining quality of life and vocational productivity. The adverse effects of sleepiness and sleeplessness are confounded by the associated burden of co-existing non-communicable diseases (NCDs) such as chronic pain, obesity, diabetes, obstructive sleep apnoea and obstructive coronary artery disease. The primary aim of the Eastern Australian Sleep and Health Livingness Study is to describe and quantify the multi-faceted interrelationship between the 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 rhythm maintenance. ‘Adjunctive’ treatments include 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 observational cohort study of adults in Eastern Australian rural and urban centres who report of impaired sleep with or without chronic bodily symptom(s). Interviewer-assisted survey and stratified sampling over a five-year period will stratified participants into case-control study for their exposure to important risk factors of impaired sleep and/or chronic bodily symptoms, pattern of health care utilisation, pattern and quality of sleep, persistence and/or development of bodily symptoms such as pain(s), tiredness and fatigability in addition to task-specific cognitive impairment and emotional well-being. The matched case-control study design of comparison of participants living in rural and urban centres offers an efficient method of testing the study hypotheses within a relatively shorter period of follow up time. It also allows testing of multiple study outcomes, different case-control scenario such as patterns of health care utilisation, calculation of time-dependent or exposure-dependent risk and minimise selection bias as compared to a large-scale population study which is most costly to implement. The currently available estimated prevalence of impaired sleep, chronic bodily symptom(s) and ‘adjunctive’ treatment is significant to reduce potential bias of risk factor exposure. Given the etiological importance of regular physical activity and adverse lifestyle factors, the study will confirm supportive sleep rhythm(s) is/are represented by a consistent pattern(s) of ‘livingness’ which is readily identifiable and reproducible. The implication of the study proposes the reorientation of our Public Health policy in practical lifestyle modification which are necessary in improving productivity and preventing the long-term complications of sleep-related disorders.
Interventions
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, exogeno
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.
Sponsors
Samuel Kim MBBS FRACP MPH MBA MMed (Sleep)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed