Active clinical trials for "Sleep Initiation and Maintenance Disorders"

Treatment of insomnia in caregivers is needed given that 60% of Alzheimer disease caregivers report sleep complaints, and insomnia may add to the burden of AD caregiving and contribute to morbidity and mortality risk. This is the first intervention trial in AD caregivers to target insomnia and also evaluate two mechanisms of chronic disease risk, inflammation and cellular aging

There is a strong association between insomnia and suicidal thoughts and behaviors. Insomnia also frequently co-occurs with other common conditions associated with suicide such as depression and posttraumatic stress disorder. This project focuses on improving sleep as a novel suicide prevention strategy that can be delivered to a broad range of Veterans. The study will examine how Cognitive Behavioral Therapy for Insomnia, an efficacious treatment for insomnia, may reduce suicidal thoughts in Veterans who also suffer from co-occurring conditions when delivered by integrated primary care clinicians.

The main purpose of this study is to assess efficacy and safety of ACT-541468 (daridorexant) in adult and elderly subjects with insomnia disorder. Efficacy will be evaluated on objective and subjective sleep parameters.

The aim of this study is to assess an online mindfulness intervention for pregnant women (6 weeks) for the treatment of insomnia and prevention of depression relapse in pregnancy. This mindfulness intervention will also be compared with an online intervention (6 weeks) consisting only of education about insomnia in pregnancy. The principal hypothesis is that the mindfulness intervention will be more effective than the education-only intervention.

A randomized controlled trial involving 140 subjects with (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) DSM-5 insomnia disorder after excluding those with other medical conditions, psychiatric disorders, and sleep disorders that may cause insomnia. The subjects will be randomly assigned to either acupuncture treatment or sham acupuncture (control group) in a 1:1 ratio. The acupuncture treatment group will receive acupuncture treatments using a semi-standardized protocol. In a similar way, the sham acupuncture control group will receive acupuncture using validated non-invasive sham acupuncture needles. Both subjective (the sleep questionnaire and sleep diary) and objective (actigraphy) outcome measures will be recorded at baseline and at 1- and 5-week post-treatment. Fasting blood samples will be taken on the morning of the assessments at these time points to measure the oxidative stress parameters, including the malondialdehyde (MDA) level, and the glutathione peroxidase (GPx), paraoxonase (PON), and arylesterase (ARE) activities. The primary outcome is sleep efficiency, measured using a 7-day sleep diary and the oxidative stress parameters at 1-week post-treatment.

Chronic spinal pain (CSP) includes chronic low back and neck pain. CSP is a highly prevalent and severely debilitating disorder characterized by tremendous personal and socioeconomic impact, long-term sick leave, low quality of life and very high socioeconomical costs. The current strategies for treating CSP are not yet optimal in reducing pain and related disability, urging the need for improvement. A possible problem is that the current approaches are often to limited and only address pain. Current treatments for CSP do not address associated complaints like sleeping problems which are however important issues. If present, sleeping problems may contribute to CSP severity and related disability. If left untreated, they represent a barrier for effective CSP management. Up to now, however, sleeping problems are hardly addressed and if so, it is mostly limited to sleeping medication. This is a problem since the efficacy and safety of drug treatment has not been established. Therefore, within the current innovative project we propose examining the added value of cognitive behavioral therapy for insomnia (CBT-I) to the current best physical therapy treatment for CSP. CBT-I includes changing negative thoughts about sleep, sleep hygiene, altering sleeping patterns, and teaching relaxation skills. The objectives of the study are to examine if CBT-I combined with the modern physical therapy approach (education about pain followed by exercise therapy) is more effective than the modern physical therapy approach alone for reducing pain, improving sleep and functionality in CSP patients with sleeping problems. Therefore 120 CSP patients with sleeping problems will be randomly divided over the 2 treatment programs (60 per group) and will be assessed before and after their 14-week therapy program consisting of 18 therapy sessions. Comparisons will be made for pain severity, sleep quality and functionality.

A randomized, controlled trial to explore whether warm footbaths with added ginger powder can improve the sleep quality of adults with self-perceived insomnia symptoms. Participants receive daily footbaths either with warm water alone or with added ginger powder over a period of 2 weeks.

The present study predict that Su-Man formula massage oil acupressure can improved sleep quality.

The purpose of this 2 month phase 2b study is to investigate the dose response of 3 doses of JNJ-42847922 (Seltorexant) (5,10 and 20 mg) compared to placebo and zolpidem on sleep onset and maintenance and to further document safety and tolerability of JNJ-42847922 (Seltorexant) upon multiple (14 days) dose administration in participants with insomnia disorder.

This study will assess the pharmacodynamic effects of SAGE-217 in approximately 42 healthy adult subjects using an insomnia model.