Clinical trials: Sleep Disorders, Intrinsic
Polypharmacy, Insomnia
MIDAS Cluster Randomized Controlled Trial of Implementation Strategies to Optimize Use of Medications in VA Clinical Settings
Scientific advances are constantly leading to better treatments. However, it is quite challenging for healthcare systems, including VA, to ask very busy providers to change the way they practice.
- Conditions
- Polypharmacy, Insomnia, Anticoagulants
- Trial name
- MIDAS cRCT (NCT05065502)
- Testing
- Academic Detailing (AD), LEAP
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- VA Office of Research and Development
Insomnia
A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)
The purpose of this study is to evaluate the long-term safety of eszopiclone (2, 3 mg) in non-elderly patients with insomnia and eszopiclone (1, 2 mg) in elderly patients with insomnia.
- Trial name
- NCT00770692
- Testing
- Eszopiclone 1 mg- Elderly, Eszopiclone 2 mg- Elderly, Eszopiclone 3 mg- Non-elderly
- Where
- 34 sites in Japan
- Volunteers
- 369 people
- Sponsor
- Eisai Co., Ltd.
Hypertension, Insomnia
To Compare the Effectiveness of Suvorexant vs Placebo on Sleep Pressure in Hypertensives With Insomnia
The purpose of this study is to compare the effectiveness and safety of suvorexant versus placebo on sleep pressure and circadian rhythm in hypertensives with insomnia.
- Trial name
- Super1 (NCT02849184)
- Testing
- suvorexant
- Where
- 3 sites in Japan
- Volunteers
- 82 people
- Sponsor
- Jichi Medical University
Sleep Apnea
A Novel Pharmacological Therapy for Obstructive Sleep Apnea
A pharmacological, non-mechanical therapy for OSA that is efficacious and tolerable remains elusive. Here the investigators study the effect on sleep apnea severity of a combination of pharmacological agents (atomoxetine and…
- Trial name
- NCT03919955
- Testing
- Atomoxetine, Oxybutynin
- Where
- United States
- Volunteers
- 117 people
- Sponsor
- Brigham and Women's Hospital
Narcolepsy
Safety and Efficacy of THN102 on Sleepiness in Narcoleptic Patients
This Phase 2 study is a 8-site, double-blind, randomised, placebo-controlled, 3-way cross-over trial, involving 3 treatments with Modafinil 300 mg or the combination drug THN102 (Modafinil/Flecainide 300 /3 mg…
- Trial name
- NCT02821715
- Testing
- THN102 300/3, THN102 300/27
- Where
- 8 sites in Belgium, France
- Volunteers
- 51 people
- Sponsor
- Theranexus
Narcolepsy, Excessive Sleepiness
Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy
This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the effect of JZP-110 on driving performance in subjects with excessive sleepiness due to narcolepsy.
- Trial name
- NCT02806908
- Testing
- JZP-110
- Where
- Netherlands
- Volunteers
- 24 people
- Sponsor
- Jazz Pharmaceuticals
Down Syndrome, Obstructive Sleep Apnea Syndrome
Obstructive Sleep Apnea and Neurocognitive and Cardiovascular Function in Children With Down Syndrome
Many individuals with Down syndrome (DS) have breathing problems during sleep. This is called obstructive sleep apnea syndrome (OSAS).
- Trial name
- TRIO (NCT01808508)
- Testing
- Continuous positive airway pressure
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Children's Hospital of Philadelphia
Idiopathic Hypersomnia
A Phase 3 Study to Assess the Safety and Efficacy of Pitolisant in Adult Patients With Idiopathic Hypersomnia
The primary objective of this study is to evaluate the safety and efficacy of pitolisant compared with placebo in treating excessive daytime sleepiness (EDS) in participants with idiopathic hypersomnia (IH) age ≥18 years.
- Trial name
- NCT05156047
- Testing
- Open-label Pitolisant, Double-blind Pitolisant
- Where
- 58 sites in United States
- Volunteers
- 214 people
- Sponsor
- Harmony Biosciences Management, Inc.
Restless Legs Syndrome
Gabapentin Enacarbil (GSK1838262) Adult Restless Leg Syndrome (RLS) Post Marketing Commitment Study
Gabapentin enacarbil (GEn; GSK1838262; HORIZANT), at a dose of 600 mg/day, is currently approved in the United States for the treatment of adults with moderate-to-severe primary Restless Legs Syndrome (RLS).
- Trial name
- CONCORD (NCT01668667)
- Testing
- GSK1838262 600 mg, GSK1838262 450 mg, GSK1838262 300 mg
- Where
- 42 sites in United States
- Volunteers
- 501 people
- Sponsor
- XenoPort, Inc.
Obstructive Sleep Apnea
A Pilot Study of Biomarkers in Obstructive Sleep Apnea
Obstructive sleep apnea (OSA) is common and is a risk factor for postoperative complications, including respiratory and cardiac events and delirium.
- Trial name
- Cytokine OSA (NCT02325687)
- Testing
- Lumbar Puncture (Standard-of-Care)
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Hospital for Special Surgery, New York
Insomnia, Sleep Initiation and Maintenance Disorders
Efficacy and Safety Study of Org 50081 (Esmirtazapine) in Elderly Participants (P05709)
This study was conducted to investigate the efficacy of treatment with Org 50081 (Esmirtazapine) compared to placebo in elderly participants with chronic primary insomnia.
- Conditions
- Insomnia, Sleep Initiation and Maintenance Disorders, Mental Disorders, Dyssomnias
- Trial name
- NCT00561821
- Testing
- Esmirtazapine
- Volunteers
- 538 people
- Sponsor
- Merck Sharp & Dohme LLC
Obstructive Sleep Apnea
Assessment of the Effect of PAP on Energy and Vitality in Mild OSA Patients: The Merge Study
The investigators wish to prospectively determine the response to CPAP in patients presenting with mild OSA. In many healthcare systems, patients with mild OSA (AHI 5-15) are not reimbursed for treatment.
- Trial name
- NCT02699463
- Testing
- Continous Positive Airway Pressure, Control Group
- Where
- 11 sites in United Kingdom
- Volunteers
- 301 people
- Sponsor
- ResMed
Obstructive Sleep Apnea
Propranolol for Sleep Apnea Therapy
The primary objective of this study is to test whether a beta blocker, propranolol, lowers the overnight heart rate sleep in obstructive sleep apnea (OSA) during CPAP withdrawal.
- Trial name
- ProSAT (NCT03049306)
- Testing
- Propranolol Oral Tablet
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Johns Hopkins University
Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF)
Clinical Trials for Elderly Patients With Multiple Disease
The CHROMED project focuses its investigation on the applicability of an integrated solution for a pathological condition which: a) is very prevalent in ageing patients and b) severely impairs quality of life: COPD with other…
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD), Congestive Heart Failure (CHF), Sleep Disordered Breathing (SDB)
- Trial name
- CHROMED (NCT01960907)
- Testing
- CHROMED monitoring system
- Where
- 6 sites in Estonia, Slovenia and 3 more
- Volunteers
- 312 people
- Sponsor
- Restech Srl
Respiratory Insufficiency, Sleep Disordered Breathing
Adjustment of Mask Pressure, for Bilevel Positive Airways Pressure Therapy, by Automated Algorithm
The aim of the study is to test the hypothesis that an automated algorithm for desired mask pressure improves breathing pattern and sleep quality in patients with hypercapnic ventilatory failure.
- Trial name
- NCT01403584
- Testing
- AutoVPAP with addition of AutoEPAP, AutoVPAP with EPAP manually selected
- Where
- Germany
- Volunteers
- 21 people
- Sponsor
- ResMed
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Examining the Effect of Acupuncture on Sleep Difficulties Related to Post Traumatic Stress Disorder
The purpose of this study was to examine if group ear acupuncture improves Post-Traumatic Stress Disorder sleep difficulties among veterans who participated in Operations Enduring Freedom and Iraqi Freedom.
- Trial name
- NCT00868517
- Testing
- True group auricular acupuncture, Wait-List Control Group
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- US Department of Veterans Affairs
Sleep Disordered Breathing
Peak(R) vs. Electrocautery in Children Undergoing Tonsillectomy With Adenoidectomy
Given the large numbers of children who undergo tonsillectomy (by the time a child is 15 years old, 13% of his/her peers will have had a tonsillectomy), the significant morbidity, and direct and indirect costs associated with…
- Trial name
- NCT02533999
- Testing
- PEAK® Plasma System, Electrosurgery
- Volunteers
- 75 people
- Sponsor
- Nemours Children's Clinic
Sleep Apnea, Obstructive, Brain Injuries, Traumatic
Feasibility of Improving Sleep Apnea Treatment Adherence After Brain Injury
Background: Obstructive sleep apnea (OSA) is a sleep disorder common among Veterans with moderate-to-severe traumatic brain injury (TBI).
- Trial name
- FISATABI (NCT04221009)
- Testing
- MI and CBT 4-session manualized intervention
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- VA Office of Research and Development
Sleep Apnea, Obstructive
Comparative Outcomes Management With Electronic Data Technology (COMET) Study
STAGE I of the COMET study was to develop an Electronic Network Informatics Infrastructure that prospectively enabled access to and the sharing of clinical and research data.
- Trial name
- COMET (NCT01461473)
- Testing
- Positive Airway Pressure (PAP), Oral Appliance (OA)
- Where
- 4 sites in United States
- Volunteers
- 131 people
- Sponsor
- Stanford University
Severe Obstructive Sleep Apnea (Apnea Hypopnea Index > 30 Events/Hour), Hypertension
Study of Cardiovascular Disease and Obstructive Sleep Apnea
The purpose of this study is to determine if two medicines (allopurinol and losartan) can influence heart and blood vessel health compared to placebo in patients with sleep apnea who are using continuous positive airway pressure…
- Trial name
- CVD/OSA (NCT01637623)
- Testing
- Losartan, Allopurinol
- Where
- 4 sites in United States
- Volunteers
- 87 people
- Sponsor
- University of Wisconsin, Madison