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NCT ID: NCT06453018 Recruiting - Clinical trials for Obstructive Sleep Apnea

Positional Therapy for Childhood Obstructive Sleep Apnoea

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

Obstructive sleep apnoea (OSA) in children is a prevalent sleep disorder associated with a wide spectrum of morbidities, including neurobehavioural, cardiovascular, and metabolic complications. Positional OSA (POSA) is one of the distinct clinical phenotypes in which obstructive respiratory events occur predominantly while sleeping in the supine position. As the majority of the OSA events in POSA occur in the supine position, positional therapy has become a reasonable non-invasive treatment strategy. The primary objectives of our study are 1) To investigate the feasibility of positional therapy in children with positional OSA; 2) To investigate the efficacy of positional therapy in children with positional OSA. Hypothesis to be tested: 1) Positional therapy is feasible in children with positional OSA. 2) Positional therapy is efficacious in children with positional OSA by reducing the severity of the OSA as measured by the obstructive apnoea hypopnoea index. Design and subjects: A prospective case-control study. 20 children aged 6 to 17 years of age with positional OSA (POSA) will be invited to join the study. Primary outcome measures: Feasibility of the use of positional device therapy; the change in the OAHI between the baseline diagnostic PSG and the home sleep study using a positional device therapy. Statistical Analysis: Continuous data will be presented as mean and standard deviation or median with the interquartile range depending on its distribution, whereas categorical data will be shown as proportions. Changes in sleep study parameters between the baseline PSG and the home sleep study using the positional device will be compared using Wilcoxon signed rank tests. Within-subject differences in the secondary outcome parameters will be tested by paired t-tests, McNemar tests, and marginal homogeneity tests for continuous, dichotomous, and categorical data respectively. Expected results: Positional therapy is practicable and efficacious in children with positional OSA by reducing the severity of the OSA.

NCT ID: NCT06452784 Recruiting - Clinical trials for Obstructive Sleep Apnea

Pre- and Postoperative Apnea-Hypopnea Index After Same-Day Discharge Bariatric Surgery

DAGBAR
Start date: May 31, 2024
Phase:
Study type: Observational

A recent development is same-day discharge in bariatric surgery, this seems to be safe if proper discharge criteria are used. However, yet there is no guideline for these discharge criteria, including for patients with (potential) Obstructive Sleep Apnea (OSA). To establish proper discharge criteria concerning OSA more information about (changes in) OSA during the first days after bariatric surgery is required. The aim of this study is to assess postoperative Apnea-Hypopnea Index (AHI) changes during the first and third night after Same-Day Discharge bariatric surgery in patients with potentially untreated OSA. Methods: Patients (n=60) will undergo a Home Sleep Apnea test , pre-operatively and during the first en third postoperative night after bariatric surgery to asses the AHI and sleep architecture.

NCT ID: NCT06447818 Recruiting - Clinical trials for Obstructive Sleep Apnea of Adult

Changes in Difficult Airway Markers After Surgery for Obstructive Sleep Apnoea Syndrome

Start date: May 15, 2024
Phase:
Study type: Observational [Patient Registry]

This study investigates the changes in difficult airway markers at 6 months post operatively in patients undergoing obstructive sleep apnoea surgery

NCT ID: NCT06432933 Recruiting - Obesity Clinical Trials

Comparison of Apnea-Hypopnea Index in Patients With or Without Preventive Oxygen Therapy After Bariatric Surgery

OXYBAR
Start date: April 9, 2024
Phase: N/A
Study type: Interventional

The best perioperative strategy for obstructive sleep apnea (OSA) in bariatric surgery remains unclear. A strategy is to monitor patients and administer preventive oxygen therapy during the first postoperative night. However it is unknown what if preventive oxygen therapy is necessary. The goal of this trial is to compare the Apnea-Hypopnea Index (AHI) in participants with or without preventive oxygen therapy. Methods: Participants are patients who underwent bariatric surgery without treated OSA and will be will be randomized into arm A or arm B: Arm A: First postoperative night in the hospital with preventive oxygen therapy (standard care), Arm B: First postoperative night in hospital without preventive oxygen therapy (intervention).

NCT ID: NCT06399575 Recruiting - Hypoxia Clinical Trials

Characterizing Hypoxic Apnea Intra-individual Repeatability

CHAIR
Start date: May 2, 2024
Phase: N/A
Study type: Interventional

Apneas (breath-holds) are increasingly being tested in human subjects to understand how the human body operates. Apneas decrease heart rate and increase blood pressure. These findings are driving current research into the effects of oxygen concentrations on the heart rate and blood pressure responses to apneas and the effect of breath-hold training on these responses. The interest in apnea research is three-fold: 1. Apneas are a nervous system stressor that can help researchers better understand the fundamental operation of the human body; 2. Elite divers can use findings from research to better their training and performance; and 3. The scientific understanding of apneas may translate to a better understanding of sleep apnea. Despite this interest, little is known about the repeatability (the consistency within a single day) and reproducibility (the consistency between days) in the heart rate and blood pressure responses to apneas. This uncertainty limits the scientific interpretations from previous results. This study aims to determine the repeatability and reproducibility of heart rate and blood pressure responses to apneas. The goals of the study are: 1. To provide greater certainty to previous results; and 2. Inform best practices for future studies. The study requires 20 healthy volunteers (10 females) and will measure heart rate, blood pressure, breathing parameters (expired gas concentrations, breathing volume and rate), and oxygen saturation. During the protocol, participants will complete two maximal voluntary apneas and five test apneas. The test apneas will all be the same length based on the longer of the two maximal voluntary apneas. Before each apnea, participants will also breathe low oxygen concentrations (hypoxia). Hypoxia provides a bigger decrease in heart rate during apneas than room air which makes it easier to see changes in heart rate responses between apneas (i.e., bigger signal-to-noise ratio). Participants will complete two identical test sessions on back-to-back days. The differences in heart rate and blood pressure responses to the five apneas within each session will determine repeatability and the differences between sessions will determine reproducibility. The investigators hypothesize that repeatability will be good and that repeatability within a session will be better than reproducibility between sessions.

NCT ID: NCT06395181 Recruiting - Clinical trials for Obstructive Sleep Apnea

Whole Food Plant-based Diet Effect on Obstructive Sleep Apnea

Start date: May 14, 2024
Phase: N/A
Study type: Interventional

This research aims to develop a better understanding and clinical knowledge of the effects of a plant based diet on severity and daytime sleepiness in Obstructive Sleep Apnea.

NCT ID: NCT06386341 Recruiting - Quality of Life Clinical Trials

QoL in OSA patiënts Treated With MMA Surgery.

QOMAS
Start date: August 2, 2023
Phase:
Study type: Observational [Patient Registry]

The aim of this observational study is to evaluate the impact of maxillomandibular advancement surgery on the quality of life in patients treated with obstructive sleep apnea. The main question it aims to answer is: Does MMA surgery in OSA patiënts improve their quality of life? Patients will answer online surverys about their QoL and there will be data collected like length, weight and blood pressure.

NCT ID: NCT06382883 Recruiting - Clinical trials for Obstructive Sleep Apnea

Lifestyle and Physical Activity as Part Of Obstructive Sleep Apnea Treatment

ELO
Start date: April 18, 2024
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to investigate the effects of an individually tailored lifestyle intervention on symptoms and severity of obstructive sleep apnea (OSA), physical activity (PA) levels and sedentary behavior (SB), as well as health and wellbeing in overweight participants with moderate to severe OSA treated with CPAP. Emphasis of the individually tailored SEMC-intervention (protocol of the Sports Medicine Outpatient Clinic of The Wellbeing Services County of Central Finland) is on increasing the amount of total physical activity. The main questions the trial aims to answer are: - Can individually tailored lifestyle intervention, in combination with CPAP therapy, alleviate the severity or symptoms of OSA in overweight participants with moderate to severe OSA? - Does the addition of an individually tailored lifestyle intervention to CPAP therapy improve the quality of life, increase physical functioning, change body composition, and increase physical activity levels or decrease sedentary behavior of participants diagnosed with moderate to severe OSA? - Can enhanced behavioral support (EBS), when integrated with lifestyle intervention and CPAP therapy, lead to more substantial and enduring changes in participants' levels of physical activity or sedentary behavior? Participants will be randomized to either SEMC-intervention group, combination of SEMC-intervention and EBS, or to a control group. In this study, it is hypothesized that participants receiving SEMC-intervention in combination with CPAP therapy will experience greater alleviation of OSA severity and symptoms, improve their quality of life, body composition and physical functioning, as well as increase physical activity levels and decrease their sedentary behavior compared to the control group. In addition, it is hypothesized that participants receiving SEMC-intervention and EBS in combination with CPAP therapy will increase their physical activity levels, and decrease their sedentary behavior to a greater extent, and these changes will be more sustained compared to merely SEMC-intervention or control group.

NCT ID: NCT06367400 Recruiting - Clinical trials for Obstructive Sleep Apnea

Validation of Pediatric Sleep Questionnaire on a Swedish Cohort

Start date: March 1, 2024
Phase:
Study type: Observational

This study is aimed to validate the questionnaire called Pediatric Sleep Questionnaire on a Swedish cohort of children from 18 months to 15 years old with obstructive sleep disordered breathing.

NCT ID: NCT06351878 Recruiting - Clinical trials for Obstructive Sleep Apnea

TipTraQ Home Sleep Test Validation Study

Start date: February 28, 2024
Phase:
Study type: Observational

A validation study has been designed to assess the performance of a home sleep test device, TipTraQ, for screening sleep apnea. The study involves participants wearing the TipTraQ device on their fingertip during a traditional sleep test, known as polysomnography (PSG), conducted in a sleep center. The performance of the device will then be evaluated by comparing the results from the TipTraQ system with those from the traditional sleep test.