RecruitingACTRN12608000628347

Role of pharmacists in sleep health –a screening, awareness and monitoring program

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?

Sponsor

University of Sydney

Enrollment

400 participants

Start Date

Jan 1, 2009

Study Type

Interventional

Conditions

Sleep Disorders

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 100 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing whether community pharmacies can help identify and support people with undiagnosed sleep disorders. Sleep problems are very common but often go undetected until they cause serious health complications. Trained pharmacists will screen customers for sleep disorders using a special tool, and the study compares a simple online screening questionnaire versus a more detailed sleep health program to see which approach works better at identifying people at risk. You may be eligible if: - You are 18 years of age or older (up to 100 years) - You take medications for cardiovascular conditions, diabetes, asthma, rhinitis, or COPD, OR you are asking about products for fatigue, energy, or weight management - You do not already have a diagnosed sleep disorder You may NOT be eligible if: - You are under 18 years of age - You already have a diagnosed sleep problem - You have a terminal or seriously debilitating illness Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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.