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Trial registered on ANZCTR
Registration number
ACTRN12608000628347
Ethics application status
Approved
Date submitted
18/09/2008
Date registered
12/12/2008
Date last updated
12/12/2008
Type of registration
Prospectively registered
Titles & IDs
Public title
Role of pharmacists in sleep health –a screening, awareness and monitoring program
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Scientific title
In people with risk of having or developing a sleep disorder, is a sleep screening done by a community pharmacy effective in identifying those at risk, and is a basic or more comprehensive screening more effective?
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Universal Trial Number (UTN)
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Trial acronym
Pharmacists and sleep health
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Sleep Disorders
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Condition category
Condition code
Respiratory
3881
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0
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Sleep apnoea
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Mental Health
3882
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0
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Other mental health disorders
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Neurological
3883
3883
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0
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Exposure involves receiving a screening questionnaire to complete in a pharmacy, and , having this questionnaire examined by a trained pharmacist immediately after completion, if identified at high risk of having/developing sleep disorder, completing a sleep diary log for every night for 2 weeks and a sleep home study using a nasal flow monitoring device for 3 consecutive night on any 3 consecutive nights during which the sleep log is being recorded. This recording will be done only once within the duration of the project. If at the time of screening, there is no risk, simple counselling on healthy sleep practices will be provided.
The nasal airflow device is called the FlowWizard® will be delivered directly to the patients house via express post, if the pharmacist determines that the patient needs further screening.
It will take about five minutes to set up and is comfortable for
all night use. It will record for three nights. After use, the recorder is returned to the Woolcock Institute
of Medical Research via self-addressed postal pack for
immediate analysis.
A simple and clear report is then sent to via email/express letter to the pharmacist who can then attach this to their overall report to the General Practitioner (GP) nominated by patient to pharmacist who can then make a decision on what
other testing may be required for the patient or what type of treatment (if
any) should be started or if further referral to a sleep physician is needed.
Scientific information about the Flow Wizard appears in text below.
The FlowWizard is a single channel sleep apnea diagnostic device. A set of nasal pressure cannula are placed over the nostrils, and recordings can be made of airflow (breathing) are sampled for up to three 9-hour periods. The device is lightweight and can be despatched and returned in the post. Data stored in the device can be downloaded to a computer for automatic scoring to estimate the number of respiratory events (apneas and hypopneas) per hour. The device is TGA-approved.
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Intervention code [1]
3427
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Early detection / Screening
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Comparator / control treatment
Screening using a questionnaire only- the questionnaires are assessed by a trained pharmacist immediately or as soon as possible after the patient completes them. The pharmacist determines the risk of the patient having or being at risk of a sleep disorder and provides a referral to a physician or if there is no risk, simple counselling on healthy sleep practices. The pharmacist counsels on one occassion - for the control group this will be on the day of the screening and for the intervention group the counselling may occur either on the day of the screening or 15 days later when patients have completed a sleep diary and have results from the FlowWizard screening. The patient will be followed in both groups after 3 months to pursue outcomes of referral or counselling, and if there are no outcomes yet(eg awaiting specialist appointments etc), the patients will be followed after another 2 months (total follow up time = 5 months).
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Control group
Active
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Outcomes
Primary outcome [1]
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Proportion of patients screened who are identified as being at risk of developing a sleep disorder, using a specfied scoring algorithm
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Assessment method [1]
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Timepoint [1]
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January -March 2009, with a 3 month follow up ie March-June 2009
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Secondary outcome [1]
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Proportion of patients screened who are diagnosed with a sleep disorder. This will be documented by conducting a project close out questionnaire with all patients to determine what changes they have made in their sleep practices, and what actions if any were taken by their physician when they presented with their referral document from the screening pharmacy.
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Assessment method [1]
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Timepoint [1]
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January -March 2009, with a 3 month follow up ie March-June 2009
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Eligibility
Key inclusion criteria
If recruitment targets have not been met through patient’s responding to the promotional phase, pharmacists will also be asked to invite all adult patients who have a dispensed medication history for any medications related to cardiovascular symptoms, diabetes, asthma, rhinitis or Chronic Obstructive Pulmonary Disease(COPD) (a checklist of medications will be provided to pharmacists). Patients inquiring about products to help fatigue and energy levels or weight reduction will also be invited to participate in the study.
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Minimum age
18
Years
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Maximum age
100
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients already with a diagnosis of a sleep problem, or those < 18 years of age, or those with terminal/debilitating illness will not be included in the study.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
Pharmacies supplying CPAP equipment in NSW/ACT will be approached using a conveniene approach. Once ~20 are recruited, they will be randomised either to a basic screening(control) arm or a comprehensive arm( intervention). They will be offered training.
Following a training, all pharmacists will be provided with promotional materials. Posters will target people with symptoms and risk factors for sleep disorders, and invite them to talk to their pharmacist. Collaborative initiatives between pharmacy and other health care professionals will be set up at this stage. The Sleep Awareness Campaign will be run for three months. This will help in patuent self selecting to partcyipate. If this process does not manage to recruit sufficient numbers of patients, pharmacists will also be asked to invite all adult patients who have a dispensed medication history for any medications related to cardiovascular symptoms, diabetes, asthma, rhinitis or COPD (a checklist of medications will be provided to pharmacists). Patients inquiring about products to help fatigue and energy levels or weight reduction will also be invited to participate in the study.
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/01/2009
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
400
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Pharmacy Guild of Australia
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Address [1]
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Level 3, 15 National Circuit, Barton ACT 2600
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Country [1]
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Australia
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Funding source category [2]
4023
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Commercial sector/Industry
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Name [2]
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Pharmacy Guild of Australia
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Address [2]
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Level 3, 15 National Circuit, Barton ACT 2600
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Country [2]
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Australia
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Primary sponsor type
University
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Name
University of Sydney
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Address
Faculty of Pharmacy, Building A15, Science Road, Camperdown, NSW 2006 Australia.
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Country
Australia
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Secondary sponsor category [1]
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Other Collaborative groups
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Name [1]
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Woolcock Institute of Medical Research
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Address [1]
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Sleep and Circadian Group, WIMR
431, Glebe Point Road, Glebe NSW, 2037.
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Country [1]
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Australia
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Secondary sponsor category [2]
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Other Collaborative groups
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Name [2]
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Woolcock Institute of Medical Research
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Address [2]
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Sleep and Circadian Group, WIMR
431, Glebe Point Road, Glebe NSW, 2037.
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Country [2]
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Human Research Ethics Committee, University of Sydney
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Ethics committee address [1]
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HREC, Room 3,Level 3, Old Teachers College, A22, Camperdown Campus, University of Sydney NSW 2006
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
5947
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Approval date [1]
5947
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23/06/2008
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Ethics approval number [1]
5947
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Ethics committee name [2]
6103
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Human Research Ethics Commitee, University of Sydney
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Ethics committee address [2]
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HREC, Room 3,Level 3, Old Teachers College, A22, Camperdown Campus, University of Sydney NSW 2006
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Ethics committee country [2]
6103
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Australia
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Date submitted for ethics approval [2]
6103
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Approval date [2]
6103
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23/06/2008
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Ethics approval number [2]
6103
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10765
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Summary
Brief summary
Sleep disorders are a significant public health issue in Australia. The direct ‘health care’ costs of sleep disorders account for only 2% of their estimated economic impact ($10.3 billion) which suggests that there may be too little investment in the prevention and treatment of sleep disorders. In a first of its kind, this project proposes to conduct a screening and awareness program to be run through community pharmacies by specially trained pharmacists. Further, the project aims to conduct a randomised controlled trial to evaluate the effectiveness of two sleep health models in the community pharmacy setting; a basic online screening tool for identification of sleep disorders versus a more comprehensive sleep screening and sleep health program for the diagnosis and reduction of patient risk factor profile for developing sleep disorders. Through the participation of pharmacists, patients with sleep disorders will have improved access to information about the diagnosis, treatment and management of their conditions, especially in rural settings. The increased awareness and education about sleep health amongst pharmacists and the general public will allow for improved identification of sleep disorders and disease management, and lead to cost savings for patients, providers and the health care system. Given previous success of pharmacy based screening and intervention programs by the research team, the project has a high likelihood of success, and will deliver very valuable outcomes. This will be the first project to test the effectiveness of community pharmacies as an alternative health care site for the improvement of sleep health outcomes in Australia, and one of the first globally.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Mr Chris Robinson
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Address
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A14 - Quadrangle
The University of Sydney
NSW 2006 Australia
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Country
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Australia
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Phone
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+61 2 93514795
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Fax
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+61 2 93513256
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Bandana Saini
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Address
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Faculty of Pharmacy, Building A15, Science Rd, Faculty of Pharmacy, Camperdown Campus, University of Sydney, Camperdown NSW 2006.
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Country
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Australia
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Phone
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+61 2 93516789
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Fax
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+61 2 93514391
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Email
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[email protected]
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No information has been provided regarding IPD availability
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
Source
Title
Year of Publication
DOI
Dimensions AI
A Comparison of Screening Methods for Sleep Disorders in Australian Community Pharmacies: A Randomized Controlled Trial
2014
https://doi.org/10.1371/journal.pone.0101003
N.B. These documents automatically identified may not have been verified by the study sponsor.
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