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Parasomnias clinical trials

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NCT ID: NCT06411509 Completed - Sleep Disturbance Clinical Trials

Integration of Tai Chi and Repetitive Transcranial Magnetic Stimulation for Sleep Disturbance in Older Adults

Start date: March 1, 2023
Phase: N/A
Study type: Interventional

This is a novel and the first study to investigate the impacts of the integrated treatment of Tai Chi (TC) and repetitive transcranial magnetic stimulation (rTMS) on sleep disturbances and the potential mechanisms of arousal system. To validate the combination of TC and rTMS as a promising approach for managing sleep disturbance in older adults, the investigators will conduct a four-arm, parallel-group, randomized controlled trial comprising a 4-week treatment phase and a 3-month follow up period. A total of 152 eligible participants will be recruited and randomly assign to the TC plus active rTMS (38 participants), TC plus sham rTMS (38 participants), TC-alone (38 participants), and low-intensity PE (38 participants) control group within two weeks after the baseline assessment. TC plus active rTMS, TC plus sham rTMS, and TC-alone will be compared with a low-intensity PE control group on insomnia severity, various sleep parameters assessed by self-report sleep diary and ActiGraph, emotional states, and physical and mental health related quality of life. The investigators have formulated two hypotheses in this study. First, the three intervention groups, relative to participants undergoing PE, will confer greater improvement in all measured outcomes at post-intervention (T1) and three-month follow-up (T2); and second, in the double-blinded groups, the TC plus active rTMS will show greater improvement in all measured outcomes than TC plus sham rTMS at T1 and T2.

NCT ID: NCT06271629 Completed - Rectal Cancer Clinical Trials

Impact of Quality of Life in the Patients With Sleep Disturbance From Low Anterior Resection Syndrome in Advanced Rectal Cancer Patients

Start date: February 26, 2022
Phase:
Study type: Observational

The preservation surgery of the anal sphincter has become a standard procedure for the treatment of rectal cancer and is now possible even when the tumor is close to the anus, thanks to the advancement of surgical techniques. This procedure allows patients to avoid a permanent artificial anus and enables them to evacuate through the anus, maintaining the continuity of the intestine, making it a highly preferred surgical option. Additionally, advancements in tumor treatments have led to improved long-term survival rates. However, this anal sphincter preservation surgery inevitably can cause functional abnormalities in the rectum, and around 90% of patients experience changes in bowel habits after surgery. The characteristic symptoms occurring after rectal cancer surgery, such as diarrhea, urgency of bowel movements, frequent bowel movements, and fecal incontinence, are referred to as Anterior Resection Syndrome (ARS). Particularly, symptoms following low anterior resection surgery for lower rectal cancer are termed Low Anterior Resection Syndrome (LARS). These symptoms are most severe immediately after surgery, persisting up to 1-2 years, with some improvement over time. However, in many patients, LARS can remain a lifelong challenge, significantly impacting their quality of life. Currently, there is no definitive method to treat LARS, and symptom management is achieved through empirical treatment methods or medications. Many patients with LARS experience these symptoms predominantly at night, and it is presumed that their sleep quality is severely compromised, significantly affecting their overall quality of life. However, there is a lack of research on the prevalence of such patients and the appropriate treatments for them.

NCT ID: NCT06224972 Completed - Sleep Disorder Clinical Trials

Evaluation of the Usability and Performance Assessment of the DormoTech VLAB Device as a Home Sleep Test

Start date: June 13, 2023
Phase:
Study type: Observational [Patient Registry]

The study is a comparative, self-controlled, randomized, prospective investigation designed to assess the usability and accuracy of the DormoTech Vlab and compare its performance with a full polysomnography (PSG) study conducted over one night in a sleep lab. For the purpose of this study, the selected PSG device used for comparison is the Nox A1 system (K192469). Participants were required to wear the DormoTech Vlab, answer questionnaires pre and post-study, and simultaneously undergo a full PSG test using the Nox system. The statistical methodology for this study was designed to ensure a comprehensive analysis of the data, adhering to the standards set by the International Council for Harmonisation (ICH) E3 guideline

NCT ID: NCT06164210 Completed - Clinical trials for Autism Spectrum Disorder

Effect of Snoezelen-Based Occupational Therapy Intervention on Sleep and Behavior Problems in Infant at Risk of Autism

Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Objective: Sleep and behavioral problems are common in infants at risk of autism. This study aims to examine the effect of Snoezelen-Based Occupational Therapy intervention on sleep and behavioral problems in infants at risk of autism. Design: Twenty-four infants (15 boys, 9 girls) at risk for autism were randomized to the intervention group (n = 12; 28.33 ± 6.52 months) and the control group (n = 9; 30.11 ± 5.20 years). The intervention group received Snoezelen-Based Occupational Therapy intervention in addition to the conventional 8-week sensory integration intervention, while the control group received only the conventional sensory integration intervention. Both groups assessed sleep and behavioral problems using the Brief Infant Sleep Questionnaire (BİSQ) and the Vineland Social-Emotional Early Childhood Scale (VSEES) pre and post eight weeks of intervention.

NCT ID: NCT06154616 Completed - Poor Quality Sleep Clinical Trials

Efficacy of Different Types of Milk in Improving Sleep Quality in Subjects With Sleep Problems (Milca)

Milca
Start date: September 15, 2023
Phase: N/A
Study type: Interventional

Randomized, controlled, double-blind intervention study, with four parallel branches depending on the product consumed, to analyze the efficacy of different types of milks on the improvement of sleep quality.

NCT ID: NCT06108115 Completed - Sleep Disturbance Clinical Trials

Smartphone-Based Intervention for Sleep Disturbance in Individuals Recovering From Alcohol Use Disorder

Start date: September 13, 2021
Phase: N/A
Study type: Interventional

In order to assess the efficacy of the rhythm stabilization component of Health Rhythms' product in addressing sleep problems, investigators will recruit 128 outpatients over the age of 18, who are in early recovery (at least 2 weeks but no more than 6 months) from Alcohol Use Disorder (AUDIT-C score >4) and are experiencing sleep problems (ISI score >/= 10). 64 of these individuals will be randomly allocated to receive the full HealthRhythms package (sensing, trending, and stabilization) on their smartphones, while 64 will be asked to consent to sensing only. The duration of the study will be 14 weeks. The primary outcome measures of the RCT will be the ISI (Insomnia Severity Index). The investigators hypothesize that those receiving the full package will demonstrate lower levels of sleep disturbance.

NCT ID: NCT06041711 Completed - Clinical trials for Postoperative Complications

GENERAL vs. REGIONAL ANESTHESIA ON SLEEP QUALITY FOR HIP ARTROPLASTY PATIENTS

Start date: July 21, 2022
Phase: N/A
Study type: Interventional

Sleep disorders can impair cognitive function, decision-making ability, exercise capacity, and immune system.Sleep disorders, which may occur in the perioperative period as short-term or long-term, affect many patients. Patients have to face with perioperative sleep disorders, and this situation can continue for a long time after surgery. Anesthetic agents may cause sleep disturbances in the postoperative period. Anesthetics can disrupt the normal sleep-wake cycle and thus cause sleep insufficiency and poor sleep quality. The relationship between general anesthesia and postoperative sleep disorders is still unclear. It is advantageous to identify patients with pre-existing sleep disorders, since the risk of postoperative sleep disturbance is high. The investigators hypothesis that regional anesthesia does not disrupt the circadian rhythm compared to general anesthesia, is more successful in pain control, and thus provides a better sleep quality for patients.

NCT ID: NCT05953324 Completed - Fatigue Clinical Trials

The Effects Of Kiwifruit Consumption On Sleep Quality, Fatigue And BMI Of Saudi Adults

Start date: January 1, 2022
Phase: N/A
Study type: Interventional

Hypothesis: Kiwifruit contains antioxidants and serotonin which may be beneficial in the treatment of sleep disruption. Aim: to assess the effects of daily intake of kiwifruit on sleep quality, fatigue, and BMI among Saudi adults with poor sleep quality. Methods: Twenty-six female participants (14 cases, and 12 controls) were included. All participants were aged ≥18 years and were Saudi and had poor sleep quality. Pregnant, lactating and participants with any chronic diseases such as cardiovascular or neurological diseases, and history of using herbal or medications for inducing sleep for the last two months were excluded. Participants in the case group consumed 2 kiwifruits 1 hour before bedtime nightly for 6 weeks and the control group did not consume kiwifruit. The Pittsburgh Sleep Quality Index (PSQI) questionnaire was used to assess sleep quality before and after kiwi consumption (score ≥ 5 indicates poor sleep quality), Fatigue Severity Scale (FSS) was used to assess fatigue and anthropometrics were measured based on the WHO guidelines. After 6 weeks, sleep quality, fatigue and BMI were compared between cases and controls. Kiwifruit consumption may improve sleep quality in adults with self-reported poor sleep quality. Further investigation of the sleep promoting properties of kiwifruit is required.

NCT ID: NCT05933746 Completed - Sleep Disturbance Clinical Trials

Sleep Hygiene Intervention on Undergraduate Students' Sleep and Stress

Start date: March 1, 2022
Phase: N/A
Study type: Interventional

Poor sleep is common among college students and likely contributes to stress. The investigators developed a brief, remotely-delivered intervention and tested whether it improves sleep hygiene and reduced sleep disturbance and stress among undergraduates.

NCT ID: NCT05879640 Completed - Critical Illness Clinical Trials

Sleep After Pediatric Critical Illness

Start date: April 18, 2022
Phase: N/A
Study type: Interventional

This study tests a pilot educational sleep intervention for children after critical care hospitalization.