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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT04876482 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Myofunctional Training for Obstructive Sleep Apnea Patients After Transoral Robotic Surgery

Start date: January 1, 2020
Phase: N/A
Study type: Interventional

Background: Obstructive Sleep Apnea Syndrome (OSA) is a kind of sleep disorder. The symptoms are intermittent, partial or complete upper airway collapse, seriously impacting oxygen saturation and oxidative stress. Some patients choose to do upper airway surgeries, but the success rate is only 60-70%. The symptoms might relapse because of aging and gaining weights. The purpose of our study is to compare the effect of transoral robotic surgery (TORS) and oropharyngeal rehabilitation (OPR) on patients after TORS. Methods: Participants above 20 years old who are newly diagnosed with mild to severe OSA (Apnea-hypopnea Index >5/h), and the physician will explain the treatment programs to every subject in clinic. Expected results: The hypothesis of this study is the success rate of surgery will be enhance by increasing tongue and jaw-opening muscle strength after OPR. The biomarkers of cardiovascular disease may decrease and both the collapse of upper airway and sleep quality may be improved after TORS and OPR.

NCT ID: NCT04875897 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Efficacy and Safety of keepMED Positive Airway Pressure Device in Patients With Obstructive Sleep Apnea

keePaOSA
Start date: September 14, 2021
Phase: N/A
Study type: Interventional

A prospective, multi-centre, single-arm, open-label, interventional study with a non-marketed medical device. The primary study objective is to assess the efficacy of the keepMED PAP device on modification of respiratory characteristics in patients with OSA at one therapy night in a sleep lab. Secondarily, the safety of the use of the device in this setting is assessed.

NCT ID: NCT04875364 Recruiting - Clinical trials for Obstructive Sleep Apnea

Do Endotypes Predict Response and Sequelae in OSA Patients

ExPRESSION
Start date: August 1, 2020
Phase: Phase 2
Study type: Interventional

This study will investigate why some people have Obstructive Sleep Apnea (OSA) and how the underlying cause may relate to OSA manifestations (including sleepiness and high blood pressure) and response to different therapeutic approaches (ie CPAP, eszopiclone, and supplemental oxygen). Understanding why someone has OSA could affect how best to treat that individual, but may also have an impact on what problems the disease might cause.

NCT ID: NCT04872816 Completed - Clinical trials for Obstructive Sleep Apnea

Obstructive Sleep Apnea and Telomere Length

Start date: July 5, 2018
Phase: Phase 2
Study type: Interventional

Obstructive sleep apnea (OSA) is a highly prevalent and morbid sleep disorder. Among the factors associated with its pathophysiology, the role of intermittent hypoxia stands out, contributing to the development of oxidative stress and inflammation. It is known that cumulative levels of these factors negatively influence the final portion of the DNA, known as telomere. In this sense, the investigators hypothesize that OSA is capable of accelerating aging process through telomere shortening mediated by inflammatory and oxidative markers. Thus, the aim of this study is to investigate the effect of OSA and its treatment with CPAP on the variation of telomere length and their associated mechanisms. For this, a randomized, double-blind, sham-controlled clinical study with 6 months duration will be conducted. We will recruit male participants with OSA diagnosis (apnea-hypopnea indexe15/hour), aged between 35-65 years and body mass index<35 kg/m2, which will be randomized to use CPAP or sham-CPAP for 6 months. Participants will visit the laboratory 7 times (baseline and after 1, 2, 3, 4, 5 and 6 months) and will be submitted to clinical and otorhinolaryngological evaluation, sleep questionnaires, polysomnography and blood collection for DNA and extraction and measurement of telomere length, as well as the expression of telomerase and oxidative and inflammatory markers (ADMA, homocysteine, cysteine, TBARS, 8-oxodG, TNF-a, IL-6 and IL-10). This project aims to contribute to the elucidation of the effect of OSA on telomere length maintenance, as well as the adjacent mechanisms to this relationship.

NCT ID: NCT04872387 Completed - Clinical trials for Obstructive Sleep Apnea

A Study to Learn More About How Safe BAY2586116 is, How it Affects the Body, How it Moves Into, Through and Out of the Body at Different Doses in Healthy Japanese Male Participants After Taking Single and Multiple Doses Through the Nose

Start date: May 11, 2021
Phase: Phase 1
Study type: Interventional

BAY2586116 is a new drug in development for the treatment of obstructive sleep apnea. This is a condition that causes breathing to repeatedly stop and start during sleep due to blocked upper airways. This is a study to learn more how safe BAY2586116 is, how it affects the body, how it moves into, through and out of the body in healthy Japanese male participants. The participants will be randomly chosen to receive 1 of 3 different doses of BAY2586116 or to receive a placebo. A placebo looks like a treatment but does not have any medicine in it. The participants will receive their study treatment either 1 single time or once a day for 5 days through a nasal spray. The participants will be in the study for a total of about 12 weeks. They will stay at their study site for either 5 or 9 days, depending on which study treatment they receive. During this time, the doctors will take blood and urine samples and check the participants' health. About 6 to 8 days after the participants receive their last treatment, the researchers will check the participants' health again. The main aim of this study is to learn more about how safe BAY2586116 is compared to the placebo. To answer this question, the researchers will count the number of participants who have medical problems that may or may not be related to the study treatment. These medical problems are also known as "adverse events" while they are in the study.

NCT ID: NCT04868422 Completed - Clinical trials for Obstructive Sleep Apnea

Telemonitoring of CPAP Therapy in Sleep Apnea Patients

Start date: August 14, 2012
Phase: N/A
Study type: Interventional

Wireless telemonitoring is compared with regular nursing procedure in terms of patient satisfaction, adherence to continuous positive pressure (CPAP) treatment and nursing time during the habituation phase of the CPAP therapy in obstructive sleep apnea syndrome (OSAS).

NCT ID: NCT04864652 Active, not recruiting - Clinical trials for Obstructive Sleep Apnea of Adult

Safety and Dosing Study of the CHILLS Cryotherapy for the Treatment of OSA

ARCTIC-1
Start date: November 30, 2020
Phase: N/A
Study type: Interventional

ARCTIC-1 is a safety and dosing study to evaluate procedure tolerability in patients with clinically diagnosed moderate or severe OSA.

NCT ID: NCT04861038 Active, not recruiting - Clinical trials for Sleep Apnea, Obstructive

Study Using Negative Pressure to Reduce Apnea

SUPRA
Start date: November 29, 2021
Phase: N/A
Study type: Interventional

The objective of this study is to determine the safety and effectiveness of the aerSleep® II device for treatment of moderate to severe Obstructive Sleep Apnea (OSA) over 24 weeks of home use in spontaneously breathing adult subjects who are intolerant of Continuous Positive Airway Pressure (CPAP) therapy.

NCT ID: NCT04858399 Completed - Clinical trials for Sleep Apnea Syndromes

Muscle Tone Change in Obstructive Sleep Apnea

OSASMumecPRO
Start date: April 21, 2021
Phase:
Study type: Observational

The study aim of the project is to investigate the differences in respiratory functions, orofacial muscle tone changes, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome. At the same time, to examine the reliability of the use of the MyotonPro evaluation method, which takes place rapidly in the literature and clinic, in the orofacial pharyngeal muscle group.

NCT ID: NCT04846400 Completed - Clinical trials for Sleep Apnea, Obstructive

Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia

ssNPA
Start date: September 1, 2021
Phase: N/A
Study type: Interventional

Children with hypotonic upper airway obstruction have a high prevalence of severe obstructive sleep apnea, which if not treated has significant clinical consequence. Available treatment approaches, such as surgery and positive airway pressure, show limited efficacy and adherence. The multidisciplinary team has developed and now proposes to further test a non-surgical, well-tolerated nasopharyngeal airway device that in initial patients has resolved even extremely severe obstructive sleep apnea, and improved patient and family quality of life.