No More Sleepless Nights in Perimenopause - an Open Label, Randomized, Parallel-group, Active Controlled Intervention Study in Perimenopausal Women With Vasomotor Symptoms and Insomnia to Investigate the Efficacy of Hormone Replacement Therapy and Cognitive Behavioral Therapy
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Reduction of Insomnia Severity
研究概览
简要总结
The goal of the clinical trial is to learn if Hormone Replacement Therapy (HRT) and Cognitive Behavioral Therapy (CBT-I) can treat insomnia in menopausal women. The main questions it aims to answer are:
- Are HRT and CBT-I effective in reducing insomnia in menopausal women?
- Are HRT and CBT-I comparable in terms of reducing insomnia severity in this population?
Researchers will compare HRT and CBT-I to an active control group, receiving sleep hygiene instructions.
Participants will:
- Complete a screening and baseline assessment
- Receive Hormone Replacement Therapy (as prescribed), Cognitive Behavioral Therapy (1/week), or sleep hygiene instructions (1/week) for 8 weeks.
- Keep a daily diary (sleep e-diary), to assess sleep-quality.
- Wear an electroencephalogram (EEG) during 6 nights (3 at baseline & 3 post-intervention), to assess deep sleep cycles and waking episodes.
- Receive a phone call for intervention compliance
- Complete a post-intervention assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 69 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Late menopausal transition according to Stages of Reproductive Aging criteria (STRAW+10)
- •Pittsburgh Sleep Quality Index (PSQI) score > 5
- •Insomnia Severity Index (ISI) score > 7
- •Somato-vegetative domain of the Menopause Rating Scale (MRS)-II ≥ 4 points
- •Willingness to use HRT for menopausal symptom reliefs
排除标准
- •Other sleep-wake disorders according to DSM-5, assessed with validated questionnaires (Sleep-Health Questionnaire, Epworth Sleepiness Scale (ESS))
- •Untreated hormonal disorder
- •Obesity (BMI ≥ 30)
- •Current psychotherapy
- •Current psychopharmacological therapy including regular sleep medication
- •History of unsuccessful CBT-I
- •Psychiatric illness
- •Substance abuse (≥ 7 cigarettes/day, no more than 2 standard WHO drinks per day, other drugs)
- •Shift work
- •Long-haul flights across different time zones in the past 3 months
- •Pregnancy and lactation
- •Contraindications to HRT according to drug information (https://www.swissmedicinfo.ch/)
- •Inability to follow procedures or insufficient knowledge of project language
- •Inability to give consent
研究组 & 干预措施
Cognitive Behavioral Therapy for insomnia (CBT-I)
Participants in this experimental arm will receive cognitive behavioral therapy specifically designed to treat insomnia (CBT-I). The therapy will be delivered over 8 weekly sessions, each lasting 60 minutes. The sessions will include techniques such as sleep restriction, stimulus control, cognitive restructuring, and relaxation training. The primary goal is to improve sleep quality and reduce the severity of insomnia.
干预措施: Cognitive Behavioural Therapy for Insomnia (CBT-I) (Behavioral)
Hormone Replacement Therapy (HRT)
Participants in this experimental arm will receive hormone replacement therapy, specifically a combination of estrogen and progesterone over the course of 8 weeks. The therapy aims to alleviate menopausal symptoms, including insomnia, by addressing hormonal imbalances.
干预措施: Hormone Replacement Therapy (HRT) (Drug)
Sleep Hygiene
Participants in this sham comparator arm will receive sleep hygiene instructions. Instructions will be delivered over 8 weekly sessions. The instructions will provide general information about healthy sleep habits, such as food and drink choices, a regular sleep schedule, evening routine, etc. Although being widely used in daily clinical practice, sleep hygiene shows no significant effect as monotherapy in patients with an established insomnia. The sleep hygiene condition in this study is matched to CBT-I in frequency and intensity of contact.
干预措施: Sleep Hygiene (Behavioral)
结局指标
主要结局
Reduction of Insomnia Severity
时间窗: Week 10
Change from baseline in Insomnia Severity Index (ISI). The ISI is a seven-item questionnaire, asking respondents to rate the severity of sleep-related symptoms on 5-point Likert scales (Ranging between 0 = not applicable and 4 = very strong). Total values may range between 0 and 28, where 0 indicates no presence of sleep-related symptoms and 28 indicates very severe symptoms.
次要结局
- Improvement in Climacteric Syndrome(Week 10)
- Changes in bio-functional age(Week 10)
- Changes in maladaptive sleep-related cognitions(Week 10)