ACTRN12620001075976招募中未知
A cluster-randomised controlled implementation trial of a new, evidence-based model of care for chronic insomnia and obstructive sleep apnoea in Australian primary care.
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 600
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •General Practitioners: We will include GPs who are currently practising in Australia and give written informed consent.
- •Insomnia: To be eligible for inclusion, a potential participant with chronic insomnia must meet diagnostic criteria based on a Sleep Condition Indicator (SCI) questionnaire score of less than or equal to 16 (which has been shown to correctly identify 89% of patients with insomnia, and correctly exclude 82% of those without) and report insomnia symptoms for at least 3 months i.e. a higher SCI score indicates better sleep. The SCI scale has been reverse-coded on GP screening forms, to align with the other questionnaires (higher scores = worse symptoms/health).
- •Obstructive Sleep Apnea (OSA): To be eligible for inclusion, a potential participant must meet the following criteria:
- •OSA-50 questionnaire score of greater than or equal to 5 (indicating high probability of moderate-severe OSA) AND Epworth sleepiness scale (ESS) score of greater than or equal to 8 (indicating at least mild symptoms of sleepiness).
- •Additional general eligibility criteria:
- •Inclusions: At least 18 years of age, able to provide informed consent and complete patient questionnaires, currently living in Australia.
排除标准
- •General exclusion criteria: Drug/alcohol problems, terminal illness, unstable or poorly controlled psychiatric illness or significant cognitive impairment which would affect patient’s ability to understand or comply with study requirements, epilepsy or muscle spasms requiring benzodiazepine, women who are currently pregnant, limited English comprehension, no access to MBS-PBS (e.g. not Australian resident or citizen), or Department of Veterans Affairs card holder. Previous investigation for OSA in the past 10 years, with or without treatment (for patients being considered for the OSA pathway).
- •Condition specific exclusion criteria are then applied to potentially eligible patients to identify those with complex OSA or complex insomnia who are not suitable for simplified management in the primary care setting and should be treated as usual/referred for specialist care.
- •OSA treatment pathway exclusion criteria: BMI>=50 Kg/m2; Chronic opioid use; Hospitalisation in past 3 months for MI, unstable angina, cardiac failure, or CVA or New York Heart Association class III or IV symptoms; Neuromuscular disease; Lung disease & wake oxygen saturation <92%; Using supplemental oxygen; Confirmed/suspected sleep hypoventilation syndromes; Previous sleepiness-related motor-vehicle accident.
- •Insomnia treatment pathway exclusion criteria: Epworth Sleepiness Scale score of 16-24, average time in bed <6h; average perceived total sleep time <3h; Shift work (rotating, nights); Circadian rhythm disorder (evidence of advanced or delayed sleep wake phase disorder).
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