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Improving the management of sleep disorders in the community

A community pharmacy-based intervention to pilot the use of actigraphy in monitoring patients with sleep disorders to improve the management of sleep disorders in the community settings

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000825853
Enrollment
110
Registered
2012-08-06
Start date
2012-08-20
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study is a pilot study to determine the potential effectiveness of a community pharmacy-based service for the management of sleep disorders in the community. This study aims to pilot the role of actigraphy as an objective measure in monitoring certain sleep disorders, and to pilot the extended role of community pharmacists in managing sleep disorders in the community. It is hypothesized that those who receive an actigraph will manage their sleep problems more effectively than those undergoing standard/usual care

Interventions

1. Wrist actigraph: - Actigraph is a 'wrist actiwatch', which has the ability to measure movement over extended periods of time using an acceloremeter to record and identify certain sleep parameters, and generate results of sleep quality, sleep quantity and sleep/wake timing. Actigraph provides an accurate estimation of sleep patterns in healthy adults and patients suspected of certain sleep disorders. A trained personnel is not a requisite for using the device, in fact actigraph has been used

1. Wrist actigraph: - Actigraph is a 'wrist actiwatch', which has the ability to measure movement over extended periods of time using an acceloremeter to record and identify certain sleep parameters, and generate results of sleep quality, sleep quantity and sleep/wake timing. Actigraph provides an accurate estimation of sleep patterns in healthy adults and patients suspected of certain sleep disorders. A trained personnel is not a requisite for using the device, in fact actigraph has been used extensively in the studies of sleep and circadian rhythm in the non-laboratory and home-based settings. In this study, the participants will be wearing the actigraph for 24-hours continuously for 7 days. On day 8, the participants will revisit the pharmacy and the pharmacist will analyse the data downloaded from the actigraph using a Sleep Consultant software to generate an on -the-spot individualised report of sleep patterns (this is the first report). The participants will receive sleep advice and possible solutions based on the results from the pharmacist. After this session (follow-up 1), the participants will continue to wear the actigraph for another 7 days and return to the pharmacy for a second review on day 15 (follow-up 2). This time, the pharmacist will compare the results from the first report with the second report (which has been downloaded during this second visit) to determine any improvement in their sleep conditions. 2. Sleep diary: - We will be using the NSF sleep diary. Sleep diary will be used in conjunction with the actigraph as both may complement each other by providing objective and subjective data. The participants will fill-in the sleep diary everyday for 7 days before revisiting the pharmacy (follow-up 1) on day 8. Data from the diary will be assessed and recorded by the pharmacist. Later the participants will continue to fill-in the sleep diary for another 7 days and return the diary to the pharmacist on day 15 (together with the actigraph) for final assessment. The participants will record their bedtime, wake time, time to fall asleep, number of nocturnal awakenings and total sleep time, plus information related to sleep hygiene, lifestyle and factors that may interrupt sleep in the sleep diary. 3. Face-to-face counselling: - Counselling face-to-face (FTF) will be conducted at two time points, i.e. during first visit (day 8) and second visit (day 15) when the participants revisit the pharmacy for follow-ups and bring along the actigraph and sleep diary for assessment. This session will be conducted by a pharmacist at the participating community pharmacy for up to 1 hour duration (maximum). The pharmacists will deliver sleep advice and possible solutions about their sleep problems based on the above sleep parameters (actigraph and sleep diary) during this session. If there is no improvement in their conditions, pharmacist can recommend a general practitioner (GP) referral for further examination. 4. Baseline Surveys: - Socio-demographic and lifestyle, health-related quality of life (HRQOL), Sleep scale scores (ESS, ISI, MAPI, IRLSSG) and community pharmacy survey. 5. End of study (Day 15 - during follow-up 2 at the community pharmacy) - a set of 'end of study' survey forms: HRQOL, Sleep scale scores and close-out survey.

Sponsors

Zaswiza Mohamad Noor
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Walk-in' customers who present at the community pharmacy to seek help for sleep-related disorders or have symptoms of sleep problems

Exclusion criteria

Those who are not able to speak, read and write in English, unable to complete the screening, refuse to give consent, pregnant and those currently under treatment with continuous positive airway pressure (CPAP).

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 21, 2026