A Phase IV, Multicentre, Prospective, Randomized Clinical Trial Investigating the Impact of Menopausal Hormone Therapy on Sleep in Peri- and Postmenopausal Women
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 172
- 试验地点
- 1
- 主要终点
- Sleep Quality
研究概览
简要总结
The Effect of Menopausal Hormone Therapy on Sleep (menoSLEEP) study is investigating the effects of menopausal hormone therapy (MHT) on sleep problems in peri- and postmenopausal women with an indication for MHT. The aim of the study is to find out whether MHT improves subjective and objective sleep quality in these women. The primary objective is to measure sleep quality using several sleep-specific questionnaires and a sleep protocol.
The study is a multicentre, prospective, unblinded, randomised controlled trial involving 172 women. Participants will be divided into groups that will either receive MHT or act as a control group. All participants will complete seven questionnaires before and after MHT and keep a sleep diary. The duration of participation will vary between 8 and 16 weeks. The results should help to improve the treatment of menopausal sleep disorders and the quality of life of women affected.
详细描述
Background and rationale
Having problems falling asleep and staying asleep (insomnia) can lead to impaired quality of life, cognitive impairment, increased risk of suicide, weight gain, cardiovascular disease and premature death. Sleep disturbances are reported by nearly one-third of the general population across all age groups. This number only increases with age, affecting nearly 50% of individuals older than 65 years. Women are more likely to experience difficulty initiating and maintaining sleep compared to men, which is dramatically increased during hormonal transitions such as pregnancy or menopause.
The sleep disorders that affect women in menopause are not only a result of increasing in age, but also of the new life situation as well as hormonal changes. In addition, the transition to menopause increases the risk of developing organic sleep disorders such as obstructive sleep apnea syndrome or restless legs syndrome.
Menopausal hormone replacement therapy (MHT) is the 1st-line treatment and most effective method for treating menopausal symptoms. Subjects with a combination of insomnia and hot flashes/night sweats (vasomotor symptoms; VMS) particularly benefit from MHT. However, women without VMS also report insomnia, and there are women with severe VMS whose sleep is not disturbed. Treatment of vasomotor symptoms can definitely reduce sleep disturbances caused by VMS in menopausal women, but has not been shown to eliminate all sleep problems.
In this context, the primary objective of the planned sudy is to investigate the exact effect of MHT on sleep patterns and problems in peri- and postmenopausal women with an indication for MHT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Informed Consent as documented by signature
- •Peri- and postmenopausal woman
- •Indication for MHT (e.g. climacteric syndrome, osteoporosis, etc.)
- •Age ≥ 18 years
- •German Speaking
排除标准
- •Obesity BMI ≥ 30 kg/m²
- •Pregnancy or Lactation
- •Status post Hysterectomy
- •Systemic hormone therapy or hormonal contraception (estrogens, progestogens, androgens) during the study and within 12 weeks prior to study entry
- •Prescribed medication for therapy of sleep problems 12 weeks prior to study entry (excluding phytotherapeutic agents and over the counter medication)
- •Medication that could distort sleep (e.g. antidepressant, anticonvulsant and antipsychotic medications)
- •Substance abuse (e.g. daily alcohol consumption, drugs in general)
- •Contraindication for menopausal hormone therapy according to swissmedicinfo.ch
- •Neoplasia of the breast or other sexual organ
- •Benign or malignant liver tumors
- •Acute or chronic liver disease
- •Cholestatic jaundice
- •Porphyria
- •Arterial or venous thromboembolic events
- •Abnormal genital bleeding of unknown cause
- •Known or suspected non-compliance due to inability to follow the procedures of the study (e.g. illiteracy, language problems, psychological disorders, dementia, etc.)
研究组 & 干预措施
Postmenopausal women with direct start of HRT
Postmenopausal women with direct start of HRT
干预措施: HRT (Drug)
Postmenopausal control group: postmenopausal women with delayed start of HRT
Postmenopausal control group: postmenopausal women with delayed start of HRT
干预措施: HRT (Drug)
Perimenopausal women with direct start of HRT
Perimenopausal women with direct start of HRT
干预措施: HRT (Drug)
Perimenopausal control group: perimenopausal women with delayed start of HRT
Perimenopausal control group: perimenopausal women with delayed start of HRT
干预措施: HRT (Drug)
结局指标
主要结局
Sleep Quality
时间窗: 8-16 weeks
Sleep quality measured with the Insomnia Severity Index (ISI), a 7-item self-report questionnaire. Each item is rated on a 5-point Likert scale from 0 to 4, yielding a total score ranging from 0 to 28. Higher scores indicate greater insomnia severity and poorer sleep quality.
次要结局
- Sleep duration (total sleep time)(8-16 weeks)
- Sleep Latency(8-16 weeks)
- Wake-time after sleep onset(8-16 weeks)
- Time in bed (TIB)(8-16 weeks)
- Sleep Efficiency (SE)(8-16 weeks)
- Sleep Regularity(8-16 weeks)
- Number of waking phases(8-16 weeks)
- Daytime sleepiness(8-16 weeks)
- Early morning awakenings(8-16 weeks)
- Number of nocturnal hot flashes(8-16 weeks)
- Satisfaction with sleep behavior(8-16 weeks)
- Impairments in daily life due to sleep problems(8-16 weeks)
- Symptoms of depression(8-16 weeks)
- Symptoms of anxiety(8-16 weeks)