University of New Brunswick
Fredericton, Nova Scotia, E3B 5A3, Canada
NCT Number: NCT04406103
New Brunswick has an aging population with Canada's highest rate of sleeping pill use. The rate of long-term (chronic) use among NB seniors is 25%, well in excess of the Canadian average of 10%. The rate of use is higher in women and increases with age, as do risks for serious harms.
Sleeping pills risks are substantial and costly, especially to seniors. Research does not support their long-term use. Risk for falls causing injuries, including hip fractures, is a leading concern. They impair mental and physical functioning resulting in a loss of independence and cause impaired driving and a higher rate of serious crashes. The rate of near-fatal and fatal overdoses from mixing sleeping pills with other drugs is on the rise. Stopping treatment can be difficult due to physical dependence and withdrawal symptoms.
Cognitive behavioural therapy for insomnia (CBTi) is recommended as the first-line treatment of chronic insomnia. Sleeping pills are only to be considered when CBTi fails. However, these recommendations are not reflected in primary care practice.
Internationally, many educational interventions targeting prescribers have been tried, yet have failed to reduce sleeping pill use. However, a 12-page pamphlet (EMPOWER) given directly to seniors in a clinical trial was associated with a large reduction in sleeping pill use. Using a similarly persuasive approach, Sleepwell (mysleepwell.ca) was developed to reduce the use of sleeping pills and facilitate CBTi access and use. Sleepwell differs from EMPOWER by providing specific information and recommendations regarding CBTi in addition to guidance on how to stop sleeping pills.
This study will evaluate the effectiveness of direct-to-patient interventions on long-term sleeping pill use.
Looking for future studies?
Notify Me65 year and older
All sexes
Interventional
Not applicable
Fredericton, Nova Scotia, E3B 5A3, Canada
The investigators are proposing to investigate direct-to-patient health promotion interventions that promote sleeping pill dose reduction and treatment discontinuation by enhancing self-efficacy through various behaviour change techniques embedded in printed information provided to patients. Seniors will be invited to participate via direct telephone contact, information sharing through seniors' organizations, education sessions for seniors, and public notices. Prospective participants will be given the option of which way they would like to participate in the research:
Option 1: full participation including baseline interview, 6-month interview, and access to specific data from the participant's personal health record); Option 2: limited participation to baseline and 6-month interviews only; and Option 3: limited participation to baseline interview and access to specific data from the participant's personal health record.
This will form two sets of participants; those who do and those who do not permit access to outcomes from their personal health record. Participants that select Options 1 or 3 will consent to their medication and health resources use being assessed objectively over a six month period. Participants that choose Options 1 or 2 will directly provide baseline information about their health, medication use, and use of health resources via communications with researchers. Similar information will be collected directly from participants in this group after six months.
Random group allocation:
Options 1 and 2: i) Sleepwell package; ii) Empower package; iii) No package Option 3: i) Sleepwell package; ii) No package
The investigators will compare the rates of reducing and stopping sleeping pill use among the different groups over 6 months. Safety outcomes including falls and hospital visits will be measured. The investigators will also track participant access to online CBTi resources using Google Analytics.
Encouraging results from this study of direct-to-patient health promotion regarding insomnia management and sleeping pill use can be utilized repeatedly over time to reach all individuals who could benefit from the intervention, leading a transformational change in insomnia management.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.
Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.
Time frame: 6 months
Time frame: 3 months
Time frame: 6 months
Relative change in BZRA dose between baseline and 6 months is 25% or greater.
Time frame: 6 months
Newly started on other sedative-hypnotics
Time frame: baseline, 6 months
BMQ
Time frame: 6 months
The count of website visits by study participants in the Sleepwell arm during 6 months
Time frame: baseline, 6 mo.
Sleep onset latency (SOL) measured in minutes
Time frame: baseline, 6 months
Total sleep time (TST) measured in minutes
Time frame: baseline, 6 months
Time spent sleeping (min.) compared to total time spent in bed (min) x 100
Time frame: baseline, 6 months
Assessment of daytime sleepiness
Time frame: baseline, 6 months
Time frame: baseline, 6 months
Time frame: baseline, 6 months
A function-based self-reported brief survey to assess risk of functional decline and death
Time frame: baseline, 6 mo.
Time frame: baseline, 6 months
Time frame: baseline, 6 months
Time frame: 6 months
Prescribers will be invited to respond to this end-of-study survey assessing their acceptability of the Sleepwell intervention. The development of this survey was informed by the Theoretical Framework of Acceptability
David Gardner
Other
Your Answers When Needing Sleep in New Brunswick (YAWNS NB): A Randomized Controlled Trial Comparing Sleepwell, EMPOWER, and Treatment as Usual for Benzodiazepine Receptor Agonist Discontinuation in Older Adults (Protocol)
Acronym: YAWNS NB
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02967185
Dyssomnias, Insomnia Chronic
View Trial DetailsNCT04598672
Chronic Disease, Disease Attributes
Oslo, Norway
View Trial DetailsNCT05917379
Anxiety, Anxiety Disorders
Hefei, Anhui, China
View Trial DetailsNCT06550388
Dyssomnias, Insomnia Chronic
Jacksonville, Florida, United States
View Trial Details