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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT06391151 Not yet recruiting - Pregnancy Clinical Trials

Effect of OSA Resulting From Chronic Tonsillitis on Pregnancy Outcomes

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

This cohort study aims to investigate the impact of obstructive sleep apnea hypopnea syndrome (OSA) resulting from chronic tonsillitis on pregnancy outcomes. We hypothesize that chronic tonsillitis-induced OSA may exacerbate pregnancy complications and increase the risk of adverse pregnancy outcomes.

NCT ID: NCT06391138 Not yet recruiting - Pregnancy Clinical Trials

The Effect of OSA on Pregnancy and Fetal Outcomes

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

This cohort study aims to investigate the impact of obstructive sleep apnea hypopnea syndrome (OSA) on pregnancy and fetal outcomes. We hypothesize that OSA may exacerbate pregnancy complications, increase the risk of adverse pregnancy outcomes and affect fetal development.

NCT ID: NCT06390345 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Functional Improvement in OSA and COPD With a Telehealth LifeStyle and Exercise Intervention

FOCuSEd
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

We will conduct a Type I hybrid effectiveness-implementation study to test an integrated telehealth intervention among 400 overweight and obese patients with COPD and OSA. We will include eligible participants receiving primary care at one of five Department of Veterans Affairs (VA) medical centers and their community-based outpatient clinics. We will randomize patients in a 1:1 ratio to the multi-component intervention or "enhanced" usual care, stratifying by age (≥65 vs. < 65) and site. Participants randomized to the intervention will receive an integrated, telehealth-delivered intervention composed of a self-directed lifestyle program and supervised pulmonary rehabilitation. At the end of 3 months, we will offer to enter a recommendation for weight management medications on behalf of eligible intervention participants. In the post-core period (months 4-12), participants will continue to have as-needed access to the lifestyle coach. For participants randomized to the "enhanced" usual care group, study staff will prompt the patient's primary care provider to refer them to existing weight loss management and pulmonary rehabilitation programs. Follow-up will occur at virtual visits at 3 and 12 months. Our primary effectiveness outcome at 1-year is quality of life measured by the SF-12 Physical Component Summary Score. Secondary effectiveness outcomes will include other measures of quality of life (including sleep related impairment), sleep disturbance, disease severity (COPD exacerbations and respiratory event index for OSA), depression, social support, weight loss and cardiovascular risk. In addition to assessing effectiveness, we will also conduct a concurrent implementation process evaluation using the RE-AIM framework.

NCT ID: NCT06381115 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

App-Based Optimization of Long-Term CPAP Adherence and Quality of Life

Start date: May 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to optimize the time of CPAP usage to at least 6 hours a night for 6 nights per week for people who have OSA with the help of a smartphone application called SmartWell24. This application aims to target CPAP adherence.

NCT ID: NCT06376383 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea

Start date: January 2025
Phase: N/A
Study type: Interventional

The primary purpose of this randomized controlled trial s to investigate whether surgical reduction of palatine tonsils (tonsillotomy) is a superior treatment compared to complete surgical removal of palatine tonsils (tonsillectomy) in adults patients with obstructive sleep apnea and concomitant enlarged tonsils in regards of perioperative and postoperative morbidity.

NCT ID: NCT06372847 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

DISE-HNS Effect Study

DISE-HNS
Start date: April 23, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the site, pattern and degree of upper airway collapse before and during hypoglossal nerve stimulation (HNS) treatment using clinical standard drug-induced sleep endoscopy (DISE) and using a novel, non-invasive method predicting site of collapse from raw polysomnography (PSG) data. Furthermore, outcomes will be compared between responders and non-responders.

NCT ID: NCT06370806 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Lifestyle Intervention for Obstructive Sleep Apnea in Women

INTERAPNEA-W
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Obesity is a major risk factor for obstructive sleep apnoea (OSA), the most common sleep-disordered breathing related to neurocognitive and metabolic syndromes, type II diabetes, and cardiovascular diseases. Although strongly recommended for this condition, there are no studies on the effectiveness of an interdisciplinary weight loss and lifestyle intervention including nutrition, exercise, sleep hygiene, and smoking and alcohol cessation in women. INTERAPNEA-Women is a randomized controlled trial with a two-arm parallel design aimed at determining the effects of an interdisciplinary tailored weight loss and lifestyle intervention on OSA outcomes. The study will include 180 females aged 18-65 with a body mass index of ≥25 kg/m2 and severe to moderate OSA randomly assigned to usual care (i.e., continuous positive airway pressure), or interdisciplinary weight loss and lifestyle intervention combined with usual care. Outcomes will be measured at baseline, intervention end-point, and six-month post-intervention, including apnoea-hypopnoea index (primary outcome), other neurophysical and cardiorespiratory polysomnographic outcomes, sleep quality, daily functioning and mood, body weight and composition, physical fitness, blood biomarkers, and health-related quality of life. INTERAPNEA may serve to establish a cost-effective treatment not only for the improvement of OSA and its vast and severe comorbidities, but also for a potential remission of this condition.

NCT ID: NCT06332404 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Hypoglossal Nerve Stimulation Therapy in Patients With Obstructive Sleep Apnea: Belgian Registry

B-HNS
Start date: March 2024
Phase:
Study type: Observational [Patient Registry]

Hypoglossal nerve stimulation (HNS) therapy (Inspire system) is intended for the treatment of patients with moderate to severe obstructive sleep apnea (OSA) who cannot be effectively treated with the first-line treatment options. Recently, the request for reimbursement of the Inspire system in Belgium was approved. The aim is to create a registry of OSA patients that are treated with HNS (Inspire system) within routine clinical care at the Antwerp University Hospital.

NCT ID: NCT06319612 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Effectiveness of Stellate Ganglion Block for the Treatment of Obstructive Sleep Apnea

Start date: March 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to test the efficacy of stellate ganglion block in Obstructive Sleep Apnea. The main question it aims to answer are: • Can stellate ganglion block improve Obstructive Sleep Apnea? Patients were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

NCT ID: NCT06319482 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

The Adherence of Proactive Sleep Apnea Therapy

Start date: April 15, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare the adherence to Positive Airway Pressure (PAP) therapy for newly diagnosed Obstructive Sleep Apnea (OSA) patients. The main question(s) it aims to answer are: 1. To compare the adherence of proactive therapy and conventional Automatic-PAP (APAP) therapy short-term (3 months) and long-term (12 months) for newly diagnosed OSA patients. 2. To compare health outcomes (AHI, nightly pressure, and patient-reported outcomes) between proactive therapy and conventional APAP therapy.