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Sleep Wake Disorders clinical trials

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NCT ID: NCT04777799 Terminated - Insomnia Clinical Trials

Effectiveness and Acceptability of a Digital Solution to Train Specific EEG Frequencies With Neurofeedback for Improving Sleep

CONNECTOSOM
Start date: May 27, 2021
Phase: N/A
Study type: Interventional

The management of insomnia includes, as a first step, a healthy lifestyle, including physical activity at appropriate times, nutritional monitoring, reduced consumption of stimulants, bedtime and wake-up times that do not vary between weekdays and weekends, banning screens at least two hours before bedtime, etc. If all these conditions are met and insomnia persists, additionnal therapies may be offered. URGOTECH has developed a connected headband allowing to practice neurofeedback in complete autonomy in subjects reporting dissatisfaction with the quality of their sleep.

NCT ID: NCT04610827 Terminated - Sleep Disorder Clinical Trials

Oral Iron Frequency for Childhood Restless Leg Syndrome/Periodic Limb Movement Disorder

Start date: November 16, 2020
Phase: Phase 4
Study type: Interventional

The purpose of this research study is to see if the level of serum ferritin differs based on how often oral iron (in the form of ferrous sulfate) is given to children with restless leg syndrome/periodic limb movement disorder.

NCT ID: NCT04340583 Terminated - Asthma Clinical Trials

Subjective Sleep Quality and Sleep Disorders in Patients With Severe Asthma

Start date: September 10, 2019
Phase:
Study type: Observational

Bronchial asthma is characterized by the presence of symptoms that vary over time and of severity. Asthma symptoms tend to worsen at night and in the early hours of the morning, and the presence of nocturnal symptoms is an important indicator of therapeutic intervention in order to control the severity of the disease. Aim of the study is to investigate sleep disorders and quality, as well as and depressive and anxiety symptoms in patients affected by severe asthma before and after 6 months of treatment with monoclonal therapy. An observational, cohort, prospective, monocentric study will be conducted to evaluate subjective quality of sleep at baseline and post monoclonal treatment.

NCT ID: NCT04133350 Terminated - Heart Failure Clinical Trials

Patients With Heart Failure With Preserved Ejection Fraction Adherence to ASV Therapy (PEP ASV)

PEP-ASV
Start date: October 16, 2019
Phase: N/A
Study type: Interventional

This is a prospective, single-arm, unblinded pilot study and registry that aims to demonstrate adherence to adaptive servo-ventilation (ASV) therapy in patients with moderate to severe sleep disordered breathing who have been recently hospitalized. ASV therapy has been linked to improved outcomes in this population, but adherence to therapy is low. The AirCurve 10 ASV device that will be used for this study employs newer technologies, such as web-based monitoring and provides patients feedback, which may increase therapy adherence and therefore improve patient outcomes.

NCT ID: NCT03897062 Terminated - Insomnia Clinical Trials

Suvorexant in the Management Comorbid Sleep Disorder and Alcohol Dependence

Start date: August 26, 2019
Phase: Phase 2
Study type: Interventional

Suvorexant (trade name Belsomra) is an orexin receptor antagonist that has TGA approval for the treatment of insomnia, characterised by difficulties with sleep onset and/or sleep maintenance. It may also have a role in addictions as the orexins play a critical role in drug addiction and reward-related behaviours. Orexins appear to be involved in both alcohol withdrawal and in alcohol seeking triggered by external cues (eg contexts or stressors) through both OX1 and OX2 receptor signalling. Chief investigator, Professor Lawrence was the first to demonstrate a role for endogenous orexin signaling in alcohol-seeking. Alcohol is known to effect the sleep of healthy and alcohol dependent individuals with effects on daytime sleepiness, physiological functions during sleep, and the development of sleep disorders. There are various estimates of the co-occurrence of insomnia and alcohol use disorder ranging from 36-72%. In alcohol dependent individuals sleep is disturbed both while drinking and for months of abstinence and abstinent sleep disturbance is predictive of relapse. This proposal aims to evaluate the use of suvorexant as a safe and effective pharmacotherapy to treat sleep disorders in alcohol dependent patients undergoing acute alcohol withdrawal and thereafter for six months. The study will also examine the effectiveness of suvorexant in reducing craving for alcohol and promoting duration of abstinence. This will be the first double blind controlled trial of suvorexant in the management of the alcohol withdrawal syndrome and maintenance of abstinence post withdrawal.

NCT ID: NCT03879044 Terminated - Clinical trials for Shift-Work Sleep Disorder

Transcranial Direct Current Stimulation Therapy for Sleepiness Related to Shift Work Disorder (tDCS-SWORD)

tDCS-SWORD
Start date: March 20, 2019
Phase: N/A
Study type: Interventional

1. To determine the effects of tDCS on subjective measures of sleepiness in night-shift workers with shift work disorder. 2. To determine the effects of transcranial direct current stimulation (tDCS) on vigilance in night-shift workers with shift work disorder.

NCT ID: NCT03760159 Terminated - Clinical trials for Cardiovascular Diseases

Minimally Invasive Detection of a Sleep Apnoea

KCG_SLEEP
Start date: November 1, 2018
Phase:
Study type: Observational

Obstructive sleep apnoea (OSA) is characterised by recurrent nocturnal respiratory interruptions, resulting from the total or partial collapse of the upper respiratory ways. This results into sleep fragmentation, metabolic and biological disorders, which alter the neuropsychological and cardiovascular systems. Nowadays, 24% of men and 9% of women aged 30 to 60 years disclose already an asymptomatic and underdiagnosed sleep disorder breathing (SDB). In subjects suffering from cardiovascular disease, prevalence of SDB is higher than in the general population, reaching 87% in people with resistant hypertension, 51% in those with heart failure and 62% in those with atrial fibrillation (to cite a few).The current diagnostic tool for SDB is polysomnography (PSG), but this is an expensive, time-consuming and uncomfortable tool, which limits its wide-spread use despite the high frequency of SDB in general and, even more, in patients suffering from cardiovascular diseases. Several screening devices exist in order to test those patients at risk of SDB, but these have several limitations, since they are not recommended in patients who are asymptomatic for apnoea, in those with cardiorespiratory diseases, nocturnal arrhythmias or neurological and metabolic co-morbidities. In other words, nowadays there isn't an efficient screening tool of SDB, mainly for those with a low pre-test probability of having SDB. Preliminary evidence suggests that the seismocardiography (SCG) and the ballistocardiography (BCG) can detect nocturnal awakening and sleep disturbances with a good sensitivity and accuracy as compared to the state-of-the-art PSG. Simultaneous recording of SCG and BCG is called kinocardiography (KCG) and has not been performed yet during sleep. The main hypothesis tested in this study is that the KCG provides sensitive and accurate measures of obstructive and central apnoea as compared to the state-of-the-art PSG. The secondary hypotheses are related to modifications in the SCG and BCG signals during the apnoea and the effects of continuous positive air pressure (CPAP) therapy. These hypotheses will be tested through a series of studies in normal volunteers and patients, as follow: - Group RESPIRATOIRYSIMUL (Study A): voluntary end-expiratory breathing cessations periods and obstructive voluntary apnoea's (n=46); - Group SBD (Study B): patients admitted for complains of sleep disturbances without cardiovascular and/or respiratory abnormalities which could induce artifacts in the KCG recording (n=50); - Group nCPAP (Study C): patients treated by nCPAP therapy (n=50); - Group UNSELECTED (Study D): unselected consecutive patients (n=100), without recruitment restrictions. Study A is an interventional study on voluntary breath holding in normal volunteers. Studies B, C and D are observational investigations recruiting subjects referred for PSG as required by their medical condition. Because the KCG device is not intrusive, the investigators do not anticipate difficulties in the enrollment. This study will not affect in any manner the regular medical care of the patients admitted to the sleep laboratory. To conclude, SDB is a widespread disease with detrimental health effects and its prevalence is supposed to increase in future years. PSG is the gold standard for diagnosis of SDB but it is an expensive, uncomfortable and time-consuming tool, limiting its use in daily clinical practice. For subjects with a high pre-test probability of SDB, portable, inexpensive and easy-to-use tools have been proposed as sleep monitoring and seem to provide accurate estimates of SDB. Although such devices seem promising, they disclose also several limitations and are not universally accepted as SDB screening devices, mainly in case of low pre-test probability of SBD. The less cumbersome KCG may screen patients for SDB accurately. One of its unique features is also that it can directly identify the consequences of SDB and nCPAP therapy on the cardiovascular system, and in especially the presence of frequently associated cardiac arrhythmias. With a more efficient pre-screening, those who are most likely to be eligible for nCPAP therapy will have a better access to the currently existing sleep laboratory facilities. The present research project has thus the potential of improving SDB patients care and health, at no additional societal costs.

NCT ID: NCT03522207 Terminated - Chronic Pain Clinical Trials

Accuracy and Efficacy of Trazodone (Desyrel) on Sleep Quality and Pain Management of TMD Patient

Start date: October 15, 2018
Phase: Phase 4
Study type: Interventional

The objective is to evaluate the accuracy and efficacity of 1 dose of trazodone in TMD patient (with chronic orofacial pain and poor sleep quality). Subject will have 3 polysomnography (PSG) over 3 weeks. The first one being the baseline. Half of the patient will receive trazodone on their 2nd PSG and placebo on their 3rd PSG, and the other half will receive placebo bedofe their 2nd PSG and trazodone for the 3rd PSG. Pain quality and sleep quality will be assessed before and after PSG. polysomnograms from baseline, placebo night and trazodone night will also be compared.

NCT ID: NCT03344562 Terminated - Clinical trials for Cerebrovascular Accident

Cranial Electrical Stimulation (CES) as Treatment for Insomnia in Patients With Subacute Stroke

Start date: February 21, 2017
Phase: N/A
Study type: Interventional

This will be a double blinded randomized clinical trial carried out at Zale-Lipshy and Parkland Hospital Inpatient Rehabilitation Facilities. Acute stroke patients with insomnia, identified by the Insomnia Severity Index (ISI), and who choose to participate in this study will be randomized to CES (Cranial Electrical Stimulation) or sham CES. Patients who do not feel they are getting adequate sleep but want to continue in the study will be given the option to receive the standard of care medication as a rescue starting on the 3rd night. Patients will receive treatment with a Fisher-Wallace CES device or Sham CES. Treatment with CES will be for 20 minutes once a day, and the treatment period will be for 7 days. Patients will be allowed to increase the intensity of the device from the suggested starting point of level 2 if they feel no improvement in sleep on night 1. Groups will be monitored with a wrist worn actigraph that records the patient's activity for the duration of the period of study and provides data on sleep latency, time spent asleep, and sleep efficiency. The outcome measures will be total minutes/hours of sleep, sleep efficiency and subjective reports of drowsiness using the Karolinska Sleepiness Scale. Actigraphic data will be collected 24 hours a day for 7 days. The total length of study will be about 24 months with a target N of 100 consented individuals and 85 participants. Patients will be allowed to exit the study at any time on their own choosing. To minimize loss of subjects, patients will have the option to choose SOC rescue starting on the third night. Patients who choose the SOC rescue will continue to be monitored with an actigraph for data collection purposes. The investigator should discontinue study participation for a given subject or withdraw the subject from study if he/she believes that continuation would be detrimental to the subject's well-being. A subject can decide to withdraw from the study at any time and for any reason.

NCT ID: NCT03169309 Terminated - Sleep Clinical Trials

The BEST Study: The Efficacy of Brain Entrainment Sleep Technology in Military Healthcare Beneficiaries

BEST
Start date: January 2017
Phase: N/A
Study type: Interventional

Brain Entrainment Technology (BET), also known as Binaural Beat Technology (BBT); is an auditory-neurophysiologic technique which uses auditory tones (often embedded in music, nature sounds or white noise) dichotically via stereo headphones to manipulate brainwave activity in turn affecting the listener's mental, physical and/or emotional state. Although this technology is widely marketed to the general public and can be found free in on the internet, only a hand full of scientific studies have shown its efficacy. This study is a follow-on study to the "Sound Mind Warrior (SMW) Study" (ClinicalTrials.gov [NCT02328690]) conducted 2012-2015 which assessed the efficacy of the technology (in the "theta" brainwave frequency) on the cardiovascular stress response in a group of service members with complaint of chronic stress. This study will now assess BET (in the "delta" brainwave frequency) on sleep quality in a population of military healthcare beneficiaries with complaint of poor sleep quality.