Treatments for Insomnia in Patients With Parkinson's Disease: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- SCOPA sleep scale
研究概览
简要总结
More than half of patients with Parkinson's have troubles with insomnia. There are several treatment options for insomnia that have been studied in the general population - however, the investigators don't know if these treatments work for patients with Parkinson's. It is possible that people with Parkinson's may have different treatment responses.
The goal of this project is to test in a pilot study the tolerability and effectiveness of pharmacologic and non-pharmacologic treatments to improve insomnia in patients with Parkinson's disease. Each participant in this study will be wearing a wrist actigrapch and fill out the sleep diary. Three main treatment strategies will be tested: Placebo Light therapy, Cognitive behavioural therapy and active light therapy, and insomnia medications. The treatment that each person will receive first will be chosen randomly. If the first therapy has not been effective, participant may choose to re-enrol in the trial with one of the remaining two therapies.
详细描述
There are now a variety of treatments that can help to manage insomnia, including non-pharmacological and pharmacologic measures. Although many of these strategies have been proven to be effective in the general population very few studies have been conducted with Parkinson's Disease (PD) patients. Insomnia in PD has unique characteristics and pathophysiology; therefore, measures to treat insomnia in the general population may be ineffective in PD.
The goal of this project is to test in a pilot study the tolerability and effectiveness of pharmacologic and non-pharmacologic treatments to improve insomnia in patients with Parkinson's disease.
Participants will come for four visits: for screening, then in 1 week, 3 weeks and 7 weeks. Study visits should take approximately 1.5 to 2 hours. During the entire period of the study, the participant will be wearing a wrist actigraph - this is a motion sensing device the size of a wristwatch. Specific instructions how to use this device and how to use the sleep diary will explained at the first visit. Participant will also be filling out sleep diaries every day, to keep track of how many hours you sleep, etc. During each of the study visits there will be an in-depth interview, and researcher will review with the participants their sleep diaries and troubleshoot any problems.
In this trial the investigators will be testing three main treatment strategies. The treatment that the patient will receive first will be chosen randomly - this is essential to properly test our strategies. Participant will know which group he/she has been assigned to. If the first therapy has not been effective for the patient, he/she may choose to re-enroll in the trial, in which case participant will receive one of the remaining two therapies. The therapies are:
- Light therapy, which patient will use for 30 minutes, starting at two hours (+/- 1 hour) before your usual bedtime. Light boxes will be provided by our team. Patient will be instructed how to use this light.
- Cognitive behavioural therapy and sleep hygiene training - This will involve education about sleep in general, giving techniques related to sleep and relaxation, tips on stress management, etc.. This will take place at the Lady Davis Institute of the Jewish General Hospital. There will be 6 weekly sessions totaling 90 minutes - most of the time this will be in a group setting, with a maximum of 6 patients per group. Light therapy will also be part of this treatment strategy.
- Insomnia medications - In this portion patient will receive medications to help them sleep. Depending on the type of patient's sleep problem, this will either be a medication called desipramine (also called Doxepin), or zopiclone (also called Imovane). Both of these medications are currently used for insomnia in people without Parkinson's. These medications will be prescribed exactly as any other medical prescription, and participant will take them as any other medical prescription.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients will be recruited from the Movement Disorder Clinics at the McGill University Health Center.
- •Patients will be eligible for inclusion if they have a diagnosis of idiopathic PD and suffer from insomnia, defined as an SCOPA-sleep nocturnal subscore of >
- •The insomnia must have been persistent for at least 6 months (by patient self-report).
- •The subjects must speak either English or French sufficiently to fill out questionnaires.
排除标准
- •Use of sedative medications at night (including sedating antidepressants). Patients may be taking non-sedating antidepressants if dose is stable for 1 month.
- •Untreated restless legs syndrome, night shift work, occupational causes of abnormal sleep pattern, or other reversible causes of insomnia detected upon baseline clinical interview. If treatment of a potentially-reversible cause is unsuccessful and insomnia is persistent >3 months following treatment initiation, patients can be enrolled.
- •Insomnia is not secondary to suboptimal dopaminergic therapy. If changes to dopaminergic therapy are required after clinical interview, patients can still be eligible for inclusion if insomnia is persistent >3 months.
- •Pre-menopausal women who are not using effective methods of birth control (note that only a small minority of women with PD are pre-menopausal, so the effects of this exclusion criterion in creating gender imbalance should be minimal).
- •Dementia, defined according to PD dementia criteria as MMSE <26/30 and ADL impairment secondary to cognitive loss, or inability to understand consent process.
- •Change to dopaminergic therapy over the preceding three months.
- •Patients with very severe PD, defined as Hoehn and Yahr of 5 (i.e. nonambulatory). Provision of sleep hygiene measures, etiology of insomnia, and potential confounds in interpretation of actigraphy in immobile patients is problematic in very advanced stages of PD.
- •Insomnia is related to untreated moderate-severe depression or anxiety. Beck depression score > 20i.e, moderate depression).
研究组 & 干预措施
Light therapy
For patients who have sleep maintenance insomnia light therapy will be administered daily. If patients suffer only from sleep onset insomnia, this light therapy will be given upon awakening in the morning. Light boxes will be provided by Litebook company. In the active therapy group, the intensity of the light will be set at 10,000 lux with a head-to-light distance of 20cm. Patients will be instructed to let the light shine indirectly on their eyes (i.e. they do not look directly at the light). Patients can be reading, eating, watching TV, etc., during the time of light therapy.
干预措施: Light box (Litebook company) (Device)
CBT and sleep hygiene training
This will involve education about sleep in general, giving techniques related to sleep and relaxation, tips on stress management, etc.. This will take place at the Lady Davis Institute of the Jewish General Hospital. There will be 6 weekly sessions totalling 90 minutes - most of the time this will be in a group setting, with a maximum of 6 patients per group. Light therapy will also be part of this treatment strategy. There will be separate gropus for English and French-speaking patients
干预措施: CBT and sleep hygiene (Behavioral)
Insomnia medications
Pharmacologic treatment will be individualized depending on patient characteristics and initial response. It will consist of two potential treatments - Doxepin or Zopiclone. Both of these agents are currently used commonly in the general population and also in PD patients. The agents will be prescribed exactly as any other medical prescription (i.e. patients will fill their own prescriptions at their own pharmacy).The decision for which agent to use will be as follows: a)If patients suffer from sleep onset insomnia (with or without sleep maintenance insomnia), or if doxepin is contraindicated, Zopiclone will be prescribedb) or b)If patients suffer from sleep maintenance insomnia only (or if Zopiclone is contraindicated), Doxepin will be the first choice agent.
干预措施: Doxepin and Zopiclone (Drug)
Placebo intervention of light therapy
The inactive/placebo intervention will be 30 minutes of light therapy, using red light below the threshold required to entrain light cycles. This therefore functions as a placebo condition for the active light therapy protocol. Patients be informed that some forms of light therapy will be expected to be less active, but we will not disclose what type of condition is inactive.
干预措施: Light box ( Litebook company) (Device)
结局指标
主要结局
SCOPA sleep scale
时间窗: 6 weeks
The SCOPA sleep scale is a disease-specific measure that has been designed to assess sleep in PD. It is divided into two sections which address occurrence of nighttime sleep problems and daytime sleepiness in PD over the past month. It has been recommended as a scale of choice for evaluation of insomnia by the Movement Disorders Task Force for Sleep assessment in PD. A nocturnal subscale score of \>7 was proposed as a cutoff to define poor sleep, based upon the global sleep assessment, a cutoff confirmed in a subsequent study.
Actigraphy
时间窗: 6 weeks
Actigraphs are motion sensing devices the size of a wristwatch, which are constantly worn by the patient. Absence of physical activity for a prolonged interval is interpreted as onset of sleep The actigraph used will be the ActiWatch Spectrum (Philips Respironics). The primary outcomes of interest with actigraphy will be total sleep time, sleep efficiency, wake after sleep onset, sleep fragmentation, and duration and number of naps (sleep onset latency will also be assessed, but will be supplemented mainly with diary, since onset latency is not reliably assessed with actigraphy).
次要结局
- Severity of motor manifestations (UPDRS)(6 weeks)
- Beck depression index(6 weeks)
- Insomnia severity Index (ISI)(6 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(6 weeks)
- The Krupp Fatigue Severity Scale(6 weeks)
- Sleep Hygiene Index(6 weeks)
- Adherence to treatment(6 weeks)
- Daily sleep dairy(6 weeks)
- Parkinson's Disease Sleep Scale (PDSS)(6 weeks)
- Clinical global impression of change(6 weeks)
- Dysfunctional Beliefs and Attitudes about Sleep, a brief version ( DBAS 16)(6 weeks)
- Epworth Sleepiness Scale (ESS)(6 weeks)
- Quality of life (PDQ-39)(6 weeks)
- Adverse events(6 weeks)
研究者
Ron Postuma
Assistant Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre