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NCT ID: NCT06397365 Not yet recruiting - Apnea, Obstructive Clinical Trials

Effect of Hypnosis on Adherence to Continuous Positive Airway Pressure.

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

The prevalence of sleep-disordered breathing is high, with an apnea-hypopnea index of over 15 per hour found in 49.7% of men and 23.4% of women in the general population (1). The gold standard treatment for sleep-disordered breathing is continuous positive airway pressure (CPAP) therapy (2). However, nearly 30% of patients are considered non-adherent to CPAP treatment (3). Moreover, the number of hours of CPAP usage has been shown to be directly associated with a reduction in objective and subjective sleepiness, and improvement in daytime functioning (4). A recent prospective study conducted in a French clinical population cohort of 5138 participants found an effect of CPAP treatment duration on reducing the risk of developing a major cardiovascular event (stroke, myocardial infarction, all-cause mortality) (5). Therefore, the poor adherence to CPAP treatment represents a public health challenge for healthcare professionals managing these patients. Several predictors for non-adherence can be identified, such as using CPAP for less than 4 hours per night during the initial treatment phase, moderate to severe obstructive sleep apnea, or low self-esteem (6). Measures aimed at promoting patient adaptation from the initiation of treatment are crucial as this period determines long-term adherence to CPAP therapy (7). Among these measures, there is the management of "physical" adverse effects such as xerostomia (using a humidifier), feeling too much or too little air (modifying CPAP pressure profiles), skin problems, and mask air leaks (interface adjustment), which are well-known and applied by health care organization providing the CPAP machines (2). On top of these "technical" problems, patients related issues such as mask-induced anxiety, psychosocial conditions, and dysfunctional thoughts about CPAP treatment may prevent patients from using their CPAP properly. Innovative tools such as psycho corporal therapies, including medical hypnosis, could be used in these situations. A recent literature review focusing on the impact of medical hypnosis on sleep disorders in adult patients found an improvement in various sleep parameters (sleep quality, insomnia complaints, frequency and/or intensity of parasomnias) in 58.4% of patients. However, in this systematic review of 24 studies, none of them explored the use of medical hypnosis in sleep-related breathing disorders (8). Hypnosis can be defined as an altered state of consciousness in which a person's attention is detached from their immediate environment and absorbed in inner experiences such as feelings, cognition, and imagery (9). Hypnotic induction involves focusing attention and imaginative involvement to the point where what is imagined seems real. By using and accepting suggestions, the clinician and the patient create a benevolent hypnotic reality with the goal of improving the patient's clinical situation (10). In the literature, there is only one clinical case report describing a benefit of medical hypnosis for CPAP tolerance in a child with cherubism (a rare fibro-osseous genetic disease-causing nasal obstruction). In this case, CPAP therapy using an oral interface was fully accepted after three hypnosis sessions and corrected the obstructive sleep breathing disorder (11). In a slightly different domain, there is a case report of successful use of medical hypnosis as an adjunct therapy for weaning from mechanical ventilation (12). Our hypothesis is that the use of medical hypnosis in CPAP-treated patients could improve the patient's perception of the treatment, making it more positive. Medical hypnosis could occur very early in the management process, with rapid learning of self-hypnosis to actively influence this crucial period for long term adherence of CPAP. The principal objective is therefore to evaluate the effects of medical hypnosis on adherence to CPAP therapy in patients with sleep-disordered breathing.

NCT ID: NCT06395181 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Whole Food Plant-based Diet Effect on Obstructive Sleep Apnea

Start date: May 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: 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: NCT06374147 Not yet recruiting - Clinical trials for Apnea of Prematurity

"Prapela® SVS Incubator Pad for Apnea of Prematurity

Prapela AOP
Start date: May 15, 2024
Phase: N/A
Study type: Interventional

The study proposes to complete the development of and then establish the safety, efficacy, and clinical risk/benefit of a novel hospital incubator pad with stochastic vibrotactile stimulation (SVS) that will provide a complementary treatment and the first improvement in the clinical management of apnea of prematurity (AOP) in over 20 years. Currently, the only approved therapy for AOP is Caffeine Citrate. The SVS mattress pad can prove to be an effective, non-invasive adjunct to Caffeine Citrate for preterm infants with potential to shorten the need for respiratory support as well as overall shortened length of stay.

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.

NCT ID: NCT06311045 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea

Obstructive Sleep Apnea (OSA) and Sex-Specific Responses to N-acetylcysteine (NAC)

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

This is a randomized controlled trial (RCT) of 4 weeks of study supplement N-acetylcysteine (NAC) versus placebo in persons with significant obstructive sleep apnea (OSA) who are receiving positive airway pressure therapy (PAP), the standard of care therapy. The purpose of the study is to determine if NAC is associated with sex-specific changes in overnight oxidative stress, inflammation, as well as endothelial dysfunction in persons with OSA.

NCT ID: NCT06295562 Not yet recruiting - Clinical trials for Obstructive Sleep Apnea of Adult

Pharmacological Treatment Targeting Endotypic Traits of Obstructive Sleep Apnea

Start date: April 1, 2024
Phase: Phase 1
Study type: Interventional

This study will recruit 66 patients with obstructive sleep apnea, comprising 33 men and 33 women, who have been referred to the sleep center by their doctors for polysomnograms (PSG). The subjects will undergo two overnight sleep PSG sessions at the sleep center. The interval between the two examinations will be at least 7 days, during which they will receive both a placebo and medication conditions, administered 1 hour before bedtime. The study drugs will include: (1) atomoxetine 80 mg and oxybutynin 5 mg; or (2) venlafaxine 37.5 mg; or (3) atomoxetine 80 mg and trazodone 100 mg. Endotypic traits will be estimated using the Phenotyping Using Polysomnography method. The primary outcome is the change in apnea-hypopnea index, and secondary outcomes include endotypic traits and sleep parameters.