View clinical trials related to Insomnia Disorder.
Filter by:Objective: to evaluate if a fully-automated diagnostic interview for insomnia disorder is suitable for clinical and research purposes (adequate sensitivity and specificity) and is acceptable to patients. Study main outcomes: 1. Concurrent validity (sensitivity and specificity) compared to a gold standard. Gold standard: clinical diagnosis of a clinician using a validated structured clinical interview for the DSM 5 criteria of insomnia disorder 2. Acceptability of the fully-automated interview. Participants: Volunteers to undergo the clinical and the automated interview will be recruited through non-probability convenience sampling from patients attending the sleep clinic at Bordeaux University Hospital between May 2023 and July 2023.
The trial aims to evaluate the effectiveness of a novel digital health application (somnovia), which was designed to increase sleep quality in persons with insomnia disorder. Therefore, 290 people with insomnia disorder will be recruited and randomized to two groups: (1) a control group, in which they may engage with any treatment for insomnia disorder and are offered access to somnovia after a delay of 6 months (i.e., Care-as-Usual [CAU]), or (2) to a treatment group that immediately receives 6-month access to somnovia and may also use CAU. The primary outcome measure is the score of the Insomnia Severity Index (ISI), collected at three months post-baseline.
This study will examine the effectiveness of digital CBT-I versus sleep hygiene education in reducing insomnia severity, sleep onset latency, and wake after sleep onset in those with insomnia disorder.
This study aims to investigate the acute effects of cannabinol (CBN) 30 mg and 300 mg, versus placebo, on sleep architecture and next-day functioning in adults aged 25-65 years with chronic insomnia disorder.
The primary objective of this study is to test the feasibility and efficacy of Internet-delivered Cognitive Behavioral Therapy (CBT) for adolescents (13 - 17 years) with sleep problems (ICBT-I). All participants will receive ICBT-I for six weeks. The investigators will also evaluate the effect of the intervention on comorbid psychiatric symptoms and function.
Multicenter, randomized, placebo-controlled, 4-arm, 4-period crossover double-blind comparative study.
Insomnia is one of the most common complaints among service-members and Veterans of recent military conflicts. Insomnia has been shown to play a causal role in mental health, hypertension, obesity, and other health conditions, increasing risk for all-cause mortality. Cognitive-Behavioral Therapy for Insomnia (CBTI) produces both short-term and sustained resolution of insomnia with fewer adverse side effects than medications, but access to behavioral sleep medicine expertise within the VA is very limited. The proposed study is compares Tele-Self CBTI to Health Education Control for improved insomnia severity among treatment-seeking Veterans with Insomnia. In this study, 200 participants will be randomized with a 50/50 chance for either Tele-Self CBTI or a Health Education Control condition. Eligible participants are Veterans who are: a) prescribed sleep medications; b) diagnosed with insomnia; and/or c) referred for clinic-based CBTI (but not yet treated) for insomnia. Participants will be identified using electronic health records (EHR) and telephone interviews. Participants' sleep will be assessed at three time points, at Baseline, 8 weeks and 6 months after Baseline. Tele-Self CBTI consists of: 1) Self-management via homework with a workbook, and 2) telephone-based nurse support. Participants will complete 6 weekly readings. The 6 weekly telephone contacts will be 20 minutes through a study nurse. Patients randomized to Health Education Control (HEC) will receive a health education workbook on 6 health topics and 6 weekly phone calls from a study nurse. All participants will continue to receive usual medical care while participating in study. Following completion of the 6 month study, Health Education group participants interested in additional help for their sleep will be referred to the Durham VA Behavioral Sleep Medicine Clinic.
Study to assess the long term safety and tolerability of daridorexant in adult and elderly subjects suffering from difficulties to sleep
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 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.