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Completed

NCT Number: NCT04406103

Protocol - Your Answers When Needing Sleep in New Brunswick

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Brunswick

Fredericton, Nova Scotia, E3B 5A3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • residents of New Brunswick, Canada
  • age 65 or older
  • English speaking
  • community dwelling with no anticipated change of address for the next 6 months
  • current user of BZRAs (3 or more bedtime doses in previous 7 days)
  • long-term user of BZRA: use 3 months or longer
  • BZRA indication: insomnia.

Exclusion criteria

  • using non-BZRA sedative-hypnotics for treating insomnia or related sleep problems (e.g., trazodone, quetiapine, tricyclic antidepressant, mirtazapine, melatonin, diphenhydramine, dimenhyrdinate)
  • use of alcohol or cannabis 3 or more nights a week for sleep problems
  • diagnosis of other sleep disorders: sleep terrors, sleep apnea, restless legs syndrome, narcolepsy, sleepwalking
  • severe anxiety disorder
  • obsessive compulsive disorder
  • severe cognitive impairment
  • dementia
  • seizure disorder
  • spinal injury
  • chronic psychotic disorder (e.g., schizophrenia)
  • bipolar disorder
  • cancer
  • receiving palliative care
  • living in a Long Term Care facility

Treatment and study plan

Sleepwell

Behavioral

Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.

EMPOWER

Behavioral

Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.

Primary outcomes

  1. Number of participants discontinuing BZRA treatment within 6 months

    Time frame: 6 months

Secondary outcomes

  1. Number of participants discontinuing BZRA treatment within 3 months

    Time frame: 3 months

  2. Number of participants with BZRA dose change of 25% or more within 6 months

    Time frame: 6 months

    Relative change in BZRA dose between baseline and 6 months is 25% or greater.

  3. Number of participants starting a new non-BZRA sedative-hypnotic

    Time frame: 6 months

    Newly started on other sedative-hypnotics

Other outcomes

  1. Score on the Beliefs about Medicines Questionnaire (BMQ)

    Time frame: baseline, 6 months

    BMQ

  2. Number of visits to mysleepwell.ca website

    Time frame: 6 months

    The count of website visits by study participants in the Sleepwell arm during 6 months

  3. Time to fall asleep (minutes)

    Time frame: baseline, 6 mo.

    Sleep onset latency (SOL) measured in minutes

  4. Time spent asleep (minutes)

    Time frame: baseline, 6 months

    Total sleep time (TST) measured in minutes

  5. Sleep efficiency (%)

    Time frame: baseline, 6 months

    Time spent sleeping (min.) compared to total time spent in bed (min) x 100

  6. Score on the Epworth Sleepiness Scale

    Time frame: baseline, 6 months

    Assessment of daytime sleepiness

  7. Score on the Insomnia Severity Index

    Time frame: baseline, 6 months

  8. Score on the Generalized anxiety disorder - 7

    Time frame: baseline, 6 months

  9. Vulnerable elderly survey, 13-item version

    Time frame: baseline, 6 months

    A function-based self-reported brief survey to assess risk of functional decline and death

  10. Score on the Quality of life SF-12v2

    Time frame: baseline, 6 mo.

  11. Number of participants reporting having a fall (subjective)

    Time frame: baseline, 6 months

  12. Number of participants reporting having a fall-related health visit

    Time frame: baseline, 6 months

  13. Responses to the prescriber acceptability survey

    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

Sponsors and collaborators

Lead sponsor

David Gardner

Other

Collaborators

  • Dalhousie University
  • University of New Brunswick

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 28, 2020
Registry last updated
Sep 7, 2023

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.

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