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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT06064630 Not yet recruiting - Clinical trials for Sleep Apnea, Obstructive

The Effect of Remote Diagnosis and Treatment on 24 Hour Ambulatory Blood Pressure Rhythm of OSA Patients

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

Epidemiological studies have shown that OSA is closely related to the occurrence and development of cardiovascular diseases, especially hypertension. At present, there are 66 million patients with moderate to severe OSA in China, and the current diagnosis and treatment of OSA is mainly completed in the sleep center of the hospital, which is time-consuming and laborious, resulting in the delayed diagnosis and treatment of a large number of patients, making about 80% of potential OSA patients have not been diagnosed and treated in time. With the development of the Internet technologies, telemedicine has been increasingly applied to the diagnosis, treatment and management of chronic diseases with its advantages of convenience, interactivity, efficiency, sharing, coherence and breaking through the limitations of time and space. Our center has initially built a remote diagnosis and treatment management model for OSA. Compared with the traditional medical model, the medical and health economic analysis shows that the OSA diagnosis and treatment model based on telemedicine is more cost-effective, but its clinical efficacy needs to be further verified. Hypertension is a common complication in OSA patients, and continuous positive airway pressure (PAP) has a significant hypertensive effect in the treatment of OSA. However, whether clinical management based on remote diagnosis and treatment mode can achieve the same therapeutic effect as traditional face-to-face diagnosis and treatment mode in improving ambulate blood pressure in OSA patients needs to be further clarified. This study will compare the improvement of ambulatory blood pressure management in patients with hypertension under the new telemedicine mode and the traditional medical mode through a single-center randomized controlled trial, so as to optimize the diagnosis and treatment process of OSA patients with hypertension, establish a more convenient and efficient remote diagnosis and treatment mode with reliable clinical outcome, and provide a theoretical basis for subsequent multi-center research and promotion

NCT ID: NCT06060756 Not yet recruiting - Endometriosis Clinical Trials

Assessment of the Occurrence of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) in Women Suffering From Endometriosis

ENDOSAS
Start date: May 2024
Phase:
Study type: Observational

This observational study aims at establishing the proportion of patients suffering from endometriosis and for whom an Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) diagnosis is established. The study participation will be offered to endometriosis patients displaying symptoms that may suggest an underlying OSAHS. OSAHS diagnosis will be made according to standard of care practice and patients will be followed up to 12 months after initiating the OSAHS treatment to fill in questionnaires assessing the impact of OSAHS treatment on various endometriosis-related symptoms

NCT ID: NCT06060717 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Evaluation of the F&P Caramel Nasal Mask, US, 2023

Start date: November 27, 2023
Phase: N/A
Study type: Interventional

The purpose of this clinical investigation is to evaluate the performance and safety of the F&P Caramel nasal mask in a home environment.

NCT ID: NCT06041750 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Postoperative Pulmonary Complications In Obstructive Sleep Apnea Patients

Start date: October 15, 2023
Phase:
Study type: Observational [Patient Registry]

It is known that perioperative respiratory complications occur more often in obstructive sleep apnea syndrome (OSAS) patients during general anesthesia. Although there are prospective RCTs in this area, the need for further and larger studies remains due to the heterogenity of the results. Moreover, the incidence of postoperative pulmonary complications in OSAS patients undergoing surgery in Turkey and the predictive factors affecting the respiratory adverse events are uncertain. Therefore, in this prospective observational cohort study, it was aimed to determine the incidence of postoperative pulmonary complications and the predictor factors associated with patient, anesthesia and surgery in surgical patients with a confirmed or highly suspected OSAS diagnosis undergoing general anesthesia.

NCT ID: NCT06023927 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Obstructive Sleep Apnea as a Risk Factor for Normal Tension Glaucoma and a Crucial Step in Preventing Blindness

Start date: June 15, 2024
Phase:
Study type: Observational

The purpose of this research study is to learn more about the relationship between Obstructive Sleep Apnea (OSA) and Normal Tension Glaucoma (NTG). OSA is a nighttime disorder of the upper airway that causes an intermittent lack of oxygen while sleeping. NTG is a type of glaucoma that occurs despite the normal intraocular pressure levels, making its detection more difficult. Left untreated, irreversible optic nerve damage and extensive vision loss can result. Previous research has shown some evidence between OSA and the development of NTG. The investigators are researching whether undergoing treatment for OSA would help to improve the vascular health to the retina, and in effect, improve the early signs of visual dysfunction seen with diagnostic testing.

NCT ID: NCT06008678 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Study of the Resvent RXiBreezeâ„¢ PAP System to Treat Obstructive Sleep Apnea

Start date: August 14, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the automatic positive airway pressure (APAP) function of the RXiBreeze PAP System in adult subjects with obstructive sleep apnea (OSA). The main questions the study aims to answer are: 1. Is apnea-hypopnea index (AHI) detection using the RXiBreeze PAP System equivalent to apnea-hypopnea index (AHI) detection using PSG? 2. What is the responder rate using the RXiBreeze PAP System? Participants will use the APAP function of the RXiBreeze PAP System while undergoing polysomnography (PSG) for two separate nights in a sleep center. During each visit, participants will also complete two patient reported outcome questionnaires: - Epworth Sleepiness Score (ESS); and - Functional Outcomes of Sleep Questionnaire (FOSQ) short form.

NCT ID: NCT05988385 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

The Effects of Successful OSA Treatment on Memory and AD Biomarkers in Older Adults Study

ESSENTIAL
Start date: January 2024
Phase: N/A
Study type: Interventional

The Effects of Successful OSA TreatmENT on Memory and AD BIomarkers in Older AduLts (ESSENTIAL) study is a 5-year, multicenter randomized open-label trial that will screen 400 cognitively normal older adults recruited from well-established sleep clinics at 4 academic medical centers, with newly diagnosed moderate-severe OSA. An expected 200 OSA patients will be then randomized to one of two groups: i) a 3-month OSA treatment by any combination of PAP, OAT, and positional therapy that results in an "effective" AHI4%< 10/hour and AHI3A<20/hour (see below); ii) a waitlist control group to receive treatment at the conclusion of the 3-month intervention period. Both groups will continue follow-up for 24 months on stable therapy to determine if sustained improvements in sleep are associated with improvement in cognitive function and AD biomarkers.

NCT ID: NCT05978505 Not yet recruiting - Clinical trials for Sleep Apnea, Obstructive

Reboxetine for Sleep Apnoea After ENT Surgery

RENTOSA
Start date: August 15, 2023
Phase: Phase 2
Study type: Interventional

This pilot study will establish the feasibility of a larger trial to investigate whether reboxetine, a medication used to treat depression, can reduce the severity of obstructive sleep apnea (OSA) including increased blood oxygenation in post-surgical OSA patients where positive airway pressure (CPAP) therapy is either frequently poorly tolerated or not an option immediately post surgery. In this randomized, placebo-controlled, double-blind study, participants will use at-home sleep monitoring equipment before and after surgery plus measures of oxygenation. They will be prescribed either reboxetine or a placebo for seven days after surgery and complete questionnaires at the beginning and end of the study.

NCT ID: NCT05944965 Not yet recruiting - OSA Clinical Trials

Pharyngeal Muscle Control Mechanisms of Atomoxetine-plus-oxybutynin in Obstructive Sleep Apnea

Start date: October 22, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

Current therapies available for obstructive sleep apnea (OSA) have varying degrees of efficacy due to the complex nature of the disorder. A reduction in pharyngeal muscle activity characterizes OSA, and recent research has shown that combining atomoxetine and oxybutynin improves OSA severity. Thus this may be a viable treatment option. However, the specific effects of these agents alone and in combination on pharyngeal muscle activity remain unknown. The current study will look at the impact of each drug on pharyngeal muscles to gain insight into the mechanisms of this combination.

NCT ID: NCT05939934 Not yet recruiting - Clinical trials for Endothelial Dysfunction

Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP Withdrawal

ORTAP
Start date: September 2023
Phase: N/A
Study type: Interventional

Obstructive sleep apnea hypopnea syndrome (OSAS) is a frequent disease with neuropsychological and cardiovascular (CV) consequences. Continuous positive pressure (CPAP), the main treatment for OSAHS, is effective on the majority of symptoms but restrictive, which can promote non-compliance. Treatment interruptions are often observed in connection with intercurrent events such as nasal obstructions or even when patients are on the move. However, randomized trials have shown that stopping treatment, even for a short time, leads to a recurrence of symptoms and significant CV disturbances (increase in blood pressure, endothelial dysfunction, cardiac repolarization disorders). It seems important to consider strategies that promote therapeutic continuity. The mandibular advancement device (MAD) is an interesting tool in this regard. MAD is as effective as CPAP on symptoms and CV data. The investigators want to assess its effectiveness as a complementary treatment during treatment discontinuation on the main consequences of OSAHS.