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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT03377621 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Whole Body Vibration for OSA

Start date: December 2, 2017
Phase: N/A
Study type: Interventional

Obstructive Sleep Apnea (OSA) is a serious medical condition which is increasing in the United States and significantly increases risks for other diseases, morbidity and mortality. The most common treatment for OSA is CPAP (Continuous Positive Airway Pressure), but this intervention has low patient compliance, significant expense ($800-2,000/set), and high inconvenience. Whole Body Vibration (WBV) training is a novel OSA intervention which could have higher patient compliance, low expense, and potentially lower morbidity and mortality and improved quality of life in this increasing patient population.

NCT ID: NCT03354520 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks

Start date: June 18, 2021
Phase: N/A
Study type: Interventional

The study is to maximize efficacy of message delivery to achieve desired Obstructive sleep apnea (OSA) adherence goal. Newly diagnosed black patients (n=390, all genders) from participating sleep clinics will be randomly exposed to either the individually tailored or standard OSA messages. Investigators will look at an effective and scalable intervention to improve OSA-related outcomes: a) clinical CVD and brain health measures and b) patient-centered outcomes. Patient-centered and adherence data will be captured via REDCap, enabling real-time application of data-driven decision rules while implementing the intervention.

NCT ID: NCT03313947 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Airway Ultrasound Prediction and Correlation

Start date: March 25, 2020
Phase: N/A
Study type: Interventional

This is a novel approach to assess the use of ultrasound to support the identification of obstructive sleep apnea syndrome (OSAS) on a screening questionnaire, and potentially to predict a difficult pediatric airway. The investigators hope to determine if a combination of simple bedside clinical tests can be used to identify OSAS in patients who present for surgery with clinical signs of OSAS but without a formal polysomnography.

NCT ID: NCT03242720 Withdrawn - Atrial Fibrillation Clinical Trials

Effects of PAP on Afib Recurrence Risk After Catheter Ablation in OSA Patients

OSA-AFIB
Start date: January 1, 2019
Phase: N/A
Study type: Interventional

With this pilot study, we are hoping to test the feasibility of a larger study in the future and to learn whether positive airway pressure therapy reduces the recurrence risk of atrial fibrillation after successful catheter ablation procedure among patients with atrial fibrillation and obstructive sleep apnea. The results from this study will help us refine the design for a future larger study, and will ultimately improve care of patients with obstructive sleep apnea and atrial fibrillation.

NCT ID: NCT03166462 Withdrawn - Clinical trials for Sleep Apnea, Obstructive

Obstructive Sleep Apnea in Elective Orthopaedic Surgery

Start date: February 8, 2018
Phase: N/A
Study type: Interventional

Demand for Total Knee Arthroplasty (TKA) and Total Hip Arthroplasty (THA) is increasing steadily and is projected to continue trending upwards in the coming years. Concomitant with that trend is the increase in prevalence of obesity. Obesity serves as a common risk factor for osteoarthritis, obstructive sleep apnea and medical complications. Obstructive Sleep Apnea (OSA) is defined as episodes of obstructive apneas and hypopneas during sleep, with daytime somnolence. It occurs commonly in obese, middle age and elderly men and has an estimated prevalence of 5% - 9%. Pre-operative screening for elective surgical procedures is a critical component of a successful surgical outcome. Patients with medical comorbidities ideally will undergo medical treatment or optimization to minimize the risk peri-operatively and post-operatively. Obstructive sleep apnea has been shown in numerous studies to be a risk factor for cardiopulmonary complications following surgery. The contributing factors include alterations in REM sleep post-operatively and opioid induced respiratory suppression post-operatively. The STOP-BANG patient questionnaire is a validated patient survey that uses both objective and subjective data to screen patients for their risk of OSA. The sensitivity of the STOP-BANG questionnaire for moderate-to-severe OSA has been estimated as high as 97.74%. Authors have also shown that higher STOP-BANG scores are independently associated with increased risk for post-operative complication. Other authors have utilized similar pre-operative questionnaires to screen for occult pulmonary disease in patients scheduled for elective joint arthroplasty. They found a slightly increased incidence of OSA in this population as compared with the national average, over 50% of which were previously undiagnosed. The American Society of Anesthesiologists task force on perioperative management of patients with OSA published extensive guidelines aimed at reducing morbidity and mortality. Improved diagnosis pre-operatively could aid in proper compliance with these guidelines. These recommendations include preferential use of regional analgesia, reduction in systemic opioids, monitoring of oxygen saturation and nonsupine posture. The mainstay of treatment for OSA is a positive pressure airway device such as Continuous Positive Airway Pressure (CPAP) or in severe cases Nasal Intermittent Positive Pressure Ventilation (NIPPV). Post-operatively continuation of these treatments in patients with known OSA is often recommended. Some authors have demonstrated reductions in Apnea-Hypopnea Index postoperatively through the use of CPAP. However, a recent meta-analysis evaluating the effect of pre-operative or post-operative CPAP in patients with OSA concluded that the use of CPAP did not reduce post-operative adverse events. Given the projected increase in demand for joint arthroplasty, the ever-increasing incidence of obesity, the ambiguity surrounding the topic and the potential to clinically impact post-operative morbidity, mortality and health care costs, shows the need for further studies.

NCT ID: NCT03155828 Withdrawn - Clinical trials for Sleep Apnea, Obstructive

Using CPAP to Improve Menstruation in Women With Polycystic Ovarian Syndrome and Obstructive Sleep Apnea

Start date: July 2016
Phase:
Study type: Observational

The purpose of this study is to determine if treatment of obstructive sleep apnea (OSA) with continuous positive airway pressure in women with both OSA and polycystic ovarian syndrome will improve the regularity of the women's menstrual cycles.

NCT ID: NCT03108417 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Home Study of Subjects Who Have Completed a Previous Continuous Negative External Pressure (cNEP) Clinical Trial

Start date: October 2017
Phase: N/A
Study type: Interventional

This study is designed to determine whether subjects who were responders to cNEP during an overnight sleep lab titration in a previous clinical trial, Study SOM-012, will maintain a response throughout the night for up to two weeks in a home setting. It will also be determined whether two weeks of home use of cNEP is associated with any adverse events.

NCT ID: NCT03047941 Withdrawn - Clinical trials for Sleep Apnea, Obstructive

Determination of Optimal Cutoff Value for Screening Severe Hypoxemic OSA (Obstructive Sleep Apnea) Patients

Start date: February 13, 2017
Phase:
Study type: Observational [Patient Registry]

The 4 following scores have been proposed to detect OSA (Obstructive Sleep Apnea): DES-OSA, STOP-Bang, P-SAP, and OSA50. The aim of this study is to evaluate the optimal cutoff value of these four scores to detect specifically serve OSA patients with hypoxemia.

NCT ID: NCT02978651 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Pitolisant (BF2.649) in the Treatment of Excessive Daytime Sleepiness in Patients With Obstructive Sleep Apnoea Syndrome, Treated or Not by Nasal Continuous Positive Airway Pressure, But Still Complaining of Excessive Daytime Sleepiness

HAROSA IV
Start date: n/a
Phase: Phase 3
Study type: Interventional

The first objective of this study is to demonstrate the efficacy and safety of pitolisant given at 10, 20, or 40 mg per day versus placebo during 12 weeks of the Double Blind period, to treat the Excessive Daytime Sleepiness (EDS) in patients with Obstructive Sleep Apnea (OSA) refusing the nasal Continuous Positive Airway Pressure (nCPAP) therapy or treated by nCPAP but still complaining of EDS. The secondary objectives of the study include assessing the long-term tolerance as well as the maintenance of efficacy of pitolisant given at 10, 20 or 40 mg per day during 39 weeks of Open Label Extension period.

NCT ID: NCT02930538 Withdrawn - Clinical trials for Obstructive Sleep Apnea

Can Postoperative Outcomes be Predicted From Asking OSA Screening Questions Pre-operatively?

Start date: November 22, 2016
Phase:
Study type: Observational

The proposed research will determine whether a 6-item screening questionnaire previously shown to correlate with moderate or severe OSA is useful for predicting postoperative outcomes in children undergoing surgery under general anesthesia.