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Sleep Apnea Syndromes clinical trials

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NCT ID: NCT05077748 Recruiting - Clinical trials for Obstructive Sleep Apnea

An 18-year Follow-up Study on OSA in a Population-based Cohort

Start date: October 20, 2021
Phase:
Study type: Observational

Our research team has established a polysomnography (PSG) quantified population-based paediatric sleep cohort in 2003 for a childhood OSA prevalence study. Subjects were recruited from 13 randomly selected primary schools. All subjects from this original cohort will be invited to join this 18-year follow-up study to repeat the following data collection: questionnaires, anthropometric measurement, sleep study, 24-hour ambulatory blood pressure (ABP) measurement, echocardiography and neurocognitive assessment.

NCT ID: NCT05067088 Recruiting - Clinical trials for Obstructive Sleep Apnea

Novel physIologiC prEdictors of Positive Airway Pressure Effectiveness

NICEPAP
Start date: January 1, 2022
Phase:
Study type: Observational

Millions of Americans suffer from high blood pressure, diabetes, strokes and motor vehicle accidents due to ineffective treatment of obstructive sleep apnea (OSA). Our preliminary data suggest that physiological causes of OSA such as easy arousability (low arousal threshold) or unstable breathing control (high loop gain) may influence effectiveness of OSA's most common treatment, continuous positive airway pressure (CPAP). The NICE-PAP study will examine how the physiologic traits that cause OSA in each individual impact CPAP effectiveness and can lead to personalized OSA treatments that improve patient lives.

NCT ID: NCT05053685 Recruiting - Clinical trials for Obstructive Sleep Apnea

Metanephrines in Obstructive Sleep Apnoea

Start date: July 29, 2020
Phase:
Study type: Observational

Although most patients have essential (unexplained) hypertension, some patients have a treatable underlying condition. One such condition is phaeochromocytoma, a tumour that produces excessive stress hormones. Left undiagnosed, patients may develop a hypertensive crisis that can be fatal. Measurements of stress hormones (both 24-hour urine collection and morning blood tests) are highly sensitive for detecting these tumours. However, these stress hormones may also be elevated in obstructive sleep apnoea (OSA) which affects 1 in 5 adults. The investigators hypothesize that in patients with OSA, blood tests will be better than 24-hr urine tests at ruling out a tumour. If this is confirmed, then OSA patients with suspected phaeochromocytoma could be investigated with a morning blood test instead of a traditional urine test, reducing unnecessary additional tests and patient anxiety. In this single site study, the investigators plan to recruit 70 patients undergoing polysomnography. 24hr urine and bloods will be measured. Patients with elevated hormone levels will undergo imaging to rule out a tumour. The primary outcome will be the accuracy of each test in ruling out a tumour. The secondary outcomes will be the relationship between stress hormone level and severity of OSA, which may help to explain the increased cardiovascular risk in patients with OSA, and the change in stress hormone level with treatment for OSA

NCT ID: NCT05053581 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Evaluation of Self-efficacy as a Predictor for CPAP-compliance in a OSAS-patients French Cohort

SAFES
Start date: May 18, 2022
Phase:
Study type: Observational

Continuous positive airway pressure (CPAP) is the reference treatment for obstructive sleep apnea syndrome (OSAS) and is effective in improving symptoms of OSAS, reducing risk of accidents and improving quality of life. However, CPAP use is less than optimal. Recommended use is between 6-8 hour per night and a common clinical and empiric benchmark has been defined for CPAP use as an average of 4h per night for 70% of the night. Approximatively 30% of patients discontinue CPAP treatment during the first weeks. Thus, it is very important to identify the factors that influence CPAP adherence during the first weeks of treatment. Biomedical factors, in particular nose respiratory abnormalities, somnolence complaints and insomnia complaints, have been widely studied but explain only 4 to 25 % of the variance in CPAP use. Interestingly, "self-efficacy" (the confidence to engage in a treatment), was found to explain more than 30 % of the variance in CPAP use. The SEMSA (Self Efficacy in Sleep apnea) questionnaire is the instrument to investigate self-efficacy related to OSAS and CPAP that has received the most attention. Retrospective studies showed that the factor "self-efficacy" of the SEMSA was related to poor CPAP adherence. Prospective studies showed that the factor "self-efficacy" of the SEMSA at baseline was associated with future CPAP use when it was completed after education information. A French version of the SEMSA has been validated by investigators in a retrospective study. They have confirmed in France that the factor "self-efficacy" of the SEMSA was related to poor CPAP adherence. No prospective study using the SEMSA has been conducted in French patients with OSAS treated with CPAP. Given the specificity of the French health care system and home care system, it is thus important to evaluate the predictive value of self-efficacy on CPAP adherence in France. The generation of predictive model would enable pretreatment prediction of those likely to have difficulty with CPAP adherence, and would serve as the basis for the development of maximally effective interventions in order to enhance CPAP adherence by patients with OSAS.

NCT ID: NCT05052216 Recruiting - Clinical trials for Pediatric Obstructive Sleep Apnea

Development of a Wearable Point of Care Monitoring Device for Pediatric Obstructive Sleep Apnea

Start date: August 25, 2022
Phase:
Study type: Observational

Background: Obstructive sleep apnea (OSA) occurs when the blockage of the airway causes a person to stop breathing involuntarily for 10 seconds or more throughout the night during sleep. Pediatric OSA can be especially concerning and can have long-term effects. Researchers want to see how a monitoring device called near-infrared spectroscopy (NIRS) compares with the traditional techniques used in children s sleep studies. Objective: To learn about oxygen levels in the brain and limbs in children with and without sleep apnea using a wearable, point-of-care biosensor. Eligibility: Children aged 3-12 who have OSA and plan to receive treatment (OSA group) or who do not have OSA (NORM group). Design: Participants will be screened with a review of their medical records. If they have taken part in other NIH studies, that data will be reviewed as well. Participants in the NORM group will have 1 overnight study visit. Those in the OSA group will have 2 overnight study visits. Participants will do an overnight sleep study. They will have a physical exam and medical history. They will have a sleep study electroencephalography (EEG). For this, electrodes will be placed on their head. They will wear a gauze cap to keep the electrodes in place. Two NIRS probes made of a soft silicon will be placed on their forehead and arm. They will follow their normal bedtime routine. Their parent will stay overnight. The OSA group will have a second study visit 2 weeks to 12 months after they start treatment for their sleep apnea. They will repeat the sleep study.

NCT ID: NCT05050383 Recruiting - Clinical trials for Obstructive Sleep Apnea

DISE: Phenotyping Obstruction Patterns

DISE-PhOP
Start date: November 12, 2021
Phase: N/A
Study type: Interventional

Drug-induced sleep endoscopy (DISE) represents an opportunity to evaluate the upper airway in sleep-like conditions. In its current clinical form, however, DISE does not routinely determine the functional impact of anatomic and neuromuscular factors on airflow obstruction. The investigators will apply nasal pressure (CPAP) during DISE to generate pressure-flow and pressure-area relationships, deriving functional determinants of upper airway obstruction during sleep. In addition, they will use objective anatomic measurements from computerized tomography (CT) and submental ultrasound. The findings will allow the investigators to streamline the upper airway exam during DISE, and will further the goal of developing personalized solutions that address specific pathogenic mechanisms of pharyngeal collapse and airflow obstruction during sleep. The investigators will use the physiologic and anatomic features derived from DISE and imaging to determine which are predictive of success to standard-of-care surgical interventions (e.g. skeletal, soft tissue, neurostimulation) .

NCT ID: NCT05040516 Recruiting - Hypertension Clinical Trials

Selenoprotein and Renalase Blood Levels in Patients With Hypertensive Heart Disease and Obstructive Sleep Apnea

Start date: January 27, 2020
Phase:
Study type: Observational [Patient Registry]

The aim of the study is to determine whether selenoprotein activity and blood renalase level correlate with subclinical hypertensive heart disease and obstructive sleep apnea. The correlation will be assessed using selected electrocardiographic, ultrasound and laboratory indicators.

NCT ID: NCT05033626 Recruiting - Clinical trials for Obstructive Sleep Apnea

Simultaneous Operations on the Thyroid Gland and Hyoid Suspension in Patients With Combined Thyroid Pathology and OSA

Start date: October 15, 2021
Phase: N/A
Study type: Interventional

Simultaneous operations on the thyroid gland and hyoid suspension in patients with combined thyroid pathology and moderate to severe OSA.

NCT ID: NCT05014529 Recruiting - Clinical trials for Obstructive Sleep Apnea

The Continuous Positive Airway Pressure Effect on Rho-associated Coiled-coil Containing Kinases Activity.

Start date: October 1, 2021
Phase:
Study type: Observational

The ROCK (Rho-associated coiled-coil containing kinases) play a critical role in the pathogenesis of cardiovascular diseases and left ventricle hypertrophy (LVH). ROCK activity can be used as a clinical biomarker for the diagnosis and monitoring of cardiovascular disorders. Obstructive sleep apnea (OSA) increase cardiovascular disease and LVH. Continuous positive airway pressure (CPAP) is the standard therapy for OSA. This study investigate the effect of CPAP on ROCK activity and left ventricle mass.

NCT ID: NCT05009901 Recruiting - Clinical trials for Obstructive Sleep Apnea of Adult

A Pilot Study of Antioxidant Therapy in Obstructive Sleep Apnea Patients

Start date: June 1, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

Sleep apnea is a common under-diagnosed medical disorder, and moderate to severe disease is found in approximately 9% of men and 4% of women. The disease is characterized by repetitive collapse of the airway during sleep, causing sleep disruption, episodic low oxygen levels, and daytime sleepiness. Also, patients with sleep apnea are at high risk of developing cardiovascular disease (including strokes and heart attacks). Partly, this is because the episodic low oxygen levels followed by higher oxygen levels due to sleep apnea results in the generation of reactive oxygen species (unstable and potentially toxic substances caused by interactions with oxygen) and a state of "oxidative stress." Oxidative stress is an important contributing factor to heart disease. We are interested in determining whether treatment with antioxidants, which are substances that help reduce oxidative stress, helps cardiovascular health in patients with sleep apnea. Specifically, we want to determine whether treatment improves blood vessel function (an early sign of heart disease), and blood/urine markers of cardiac risk (i.e., inflammation and oxidative stress). Eighty adult patients with moderate to severe sleep apnea will be asked to participate. They will have their blood vessel function measured with a non-invasive finger probe, and blood/urine will be collected to measure the cardiac risk markers. Patients will then be 'randomized' to one of two groups: 50% chance that the patient will be asked to take an antioxidant, and a 50% chance that they will be asked to take a placebo tablet (though he/she will not know which one they are taking). After 8 weeks, blood vessel function and markers will be remeasured to determine if antioxidants help patients with sleep apnea.