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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT03796078 Recruiting - OSA Clinical Trials

Maxillomandibular Advancement in the Treatment of Obstructive Sleep Apnea

Start date: April 30, 2018
Phase: N/A
Study type: Interventional

ABSTRACT OBJECTIVES: To study the correlation between pharyngeal airway volume (PAV), the clinical indicators of obstructive sleep apnea (AHI, ESS), and the impact of orthognathic surgery on them. METHODS: A prospective, descriptive, unicentric study carried out by a multidisciplinary team to evaluate the following parameters in patients undergoing orthognathic surgery at Maxillofacial institute Teknon medical center. During the study period: - Record of the type, magnitude and direction of surgical movements of the maxillofacial complex made during the surgery (Day 0-Month 1). - Assessment of PAS/PAV stability (relapse) at short term (1 month). 3D PAV assessment by cranial voxel-based superimposition protocol before and one month and 12 months after orthognathic surgery. - Household polysomnography (PSG) registry/ apnea-hypopnea index (Day 0, Month 1 and Month 12). (AHI evaluation bu neurophysiologist) - Assessment of the clinical indicators of obstructive sleep apnea at day 0, month 1 and month 12:, blood pressure (mm Hg) , and daytime hypersomnia test (Epworth sleepiness scale, ESS) (Day 0, Month 1 and Month 12). - Record of body mass index (BMI) (cm/Kg2) Main Objective: • Evaluate the impact of orthognathic surgery (bimaxillary or monomaxillary) and its movements on the PAV and the clinical indicators of OSA. Specific objectives: • Interrelate the degree of dentofacial deformity with the IAH. - Study the potential correlation between the volume of the VAS and the IAH. - Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with PAV/PAS increase Correlate the type, direction and magnitude of the surgical movements of the maxillofacial complex with the cure of OSA (household PSG AHI assessment) and the following clinical indicators of OSA: diurnal hypersomnia test (ESD, ESS). - Evaluate negative effects of either maxillary or mandibular surgical movements in PAS/PAV increase and the cures of OSA. Evaluate negative effects of either maxillary or mandibular surgical movements in the improvement of the clinical symptoms and the cure of OSA. - To study the possible effect of surgical complications on PAS/PAV stability at long term and the clinical symptoms of OSA. - Demonstrate that maxillomandibular surgery is a defined, predictable and a definitive cure for OSA. - Demonstrate that skeletal, linear, and cross-sectional volume parameters remain stable at long-term. - Demonstrate that AHI and OSA-related parameters stay stable at long term after mono- or bimaxillary surgery. Hypothesis - H1a: Maxillomandibular advancement (orthognathic surgery) does correlate with the volume of the upper airway, at both short or long term. - H2a: Maxillomandibular advancement (orthognathic surgery) does correlate with the clinical indicators of obstructive sleep apnea, at both short or long term.

NCT ID: NCT03776084 Recruiting - Clinical trials for Sleep Apnea, Obstructive

Compliance With Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Syndrome

CPAPSH
Start date: June 1, 2019
Phase:
Study type: Observational

The aim of the study is to know the adherence to treatment and compliance of patients diagnosed with SAHS and with indication of CPAP from the sleep unit of the Hospital de Sabadell.

NCT ID: NCT03757169 Recruiting - Hypertension Clinical Trials

Isometric Hand Grip Training in Obstructive Sleep Apnea (OSA)

OSA
Start date: December 17, 2017
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) is a common clinical condition, involving the development of arterial hypertension. A Meta analysis study have shown that isometric hand grip training promotes blood pressure reduction. It is going to be conducted a clinical trail to determine the effects of hand grip training in OSA patients to change the arterial hypertension.

NCT ID: NCT03736382 Recruiting - Clinical trials for Obstructive Sleep Apnea

Mild Intermittent Hypoxia and Its Multipronged Effect on Sleep Apnea

Start date: November 15, 2018
Phase: N/A
Study type: Interventional

Mild intermittent hypoxia (IH) initiates sustained increases in chest wall and upper airway muscle activity in humans. This sustained increase is a form of respiratory plasticity known as long-term facilitation (LTF). Repeated daily exposure to mild IH that leads to the initiation of LTF of upper airway muscle activity could lead to increased stability of the upper airway. In line with PI's laboratory's mandate to develop innovative therapies to treat sleep apnea, this increased stability could ultimately reduce the continuous positive airway pressure (CPAP) required to treat obstructive sleep apnea (OSA) and improve compliance with this gold standard treatment. Improved compliance could ultimately serve to mitigate those comorbidities linked to sleep apnea. Moreover, in addition to improving CPAP compliance numerous studies indicate that mild IH has many direct beneficial effects on cardiovascular, neurocognitive and metabolic function. Thus, mild IH could serve as a multipronged therapeutic approach to treat sleep apnea. In accordance with this postulation, our proposal will determine if repeated daily exposure to mild IH serves as an adjunct therapy coupled with CPAP to mitigate associated co-morbidities via its direct effects on a variety of cardiovascular, metabolic and neurocognitive measures and indirectly by improving CPAP compliance. Modifications in autonomic (i.e. sympathetic nervous system activity) and cardiovascular (i.e. blood pressure) function will be the primary outcome measures coupled to secondary measures of metabolic and neurocognitive outcomes.

NCT ID: NCT03735004 Recruiting - Clinical trials for Transcranial Electrical Stimulation

Transcranial Electrostimulation and Obstructive Sleep Apnea Surgery

Start date: July 18, 2017
Phase: N/A
Study type: Interventional

Postoperative pain after major surgery for obstructive sleep apnea (OSA), such as palatopharyngoplasty (PPP) and maxillomandibular advancement (MMA) is moderate-to-severe, and may persist for weeks. Control of this pain may be difficult, because OSA patients are very sensitive to traditional opioid pain medications, and their side effects. Poorly controlled pain slows down patients' recovery after surgery, including a return to normal daily activities and work, and may also delay wound healing. This study will investigate whether pain relief and recovery after surgery may be improved with the application of a weak electrical current to the skin of the patient's head (transcranial electrostimulation, TES). The TES works by blocking pain in the central nervous system through multiple mechanisms, which result in non-pharmacological pain relief, without drug-associated side effects.

NCT ID: NCT03725956 Recruiting - Clinical trials for Obstructive Sleep Apnea

Polysomnographic Findings in Nasal Polyposis

POLYSOMNO
Start date: January 17, 2019
Phase: N/A
Study type: Interventional

Nasal polyposis (NP) is a chronic inflammatory disease of the nasal and sinus mucosa leading to protrusion of edematous polyps in the nasal cavity. Prevalence of NP among the chronic rhinosinusitis patients is 25-30 %. NP leads to significant limitations in physical, emotional and social aspects of life of the affected patients. Sleep disorder is frequently reported by those patients with impaired nasal breathing. Till now few studies have objectively assessed the impact of NP on sleep quality. the objectives are to figure out sleep disturbances in NP and to analyze the outcomes of sinus surgery on sleep recovering.

NCT ID: NCT03718858 Recruiting - Clinical trials for Obstructive Sleep Apnea

The Impact of Interscalene Block on Sleep Disordered Breathing

OSA-ISB
Start date: July 23, 2021
Phase: N/A
Study type: Interventional

This is a randomized controlled trial evaluating the impact of interscalene block on worsening of upper airway collapse in sleep disordered breathing for patients undergoing ambulatory shoulder surgery.

NCT ID: NCT03695315 Recruiting - Clinical trials for Obstructive Sleep Apnea

Tissue-specific Insulin Resistance in Obstructive Sleep Apnea: Role of Hypoxia

Start date: October 31, 2018
Phase:
Study type: Observational

Obstructive sleep apnea (OSA) is a common condition associated with significant adverse health outcomes. Our overarching hypothesis is that patients with OSA and hypoxia (H-OSA) have greater degrees of insulin resistance in both liver and adipose tissue when compared to those without hypoxia (NH-OSA) thus leading to increased risk for the development of diabetes in the former group.

NCT ID: NCT03646552 Recruiting - Clinical trials for Obstructive Sleep Apnea

A Study to Examine the Efficacy of a Therapeutic THX-110 for Obstructive Sleep Apnea

Start date: June 4, 2018
Phase: Phase 2
Study type: Interventional

This is a sponsored proof of concept study with the purpose to examine the safety, tolerability and feasibility of THX-110 (Dronabinol (synthetic Δ9-THC) and PEA) for the treatment of adults with Obstructive Sleep Apnea.

NCT ID: NCT03618719 Recruiting - Clinical trials for Obstructive Sleep Apnea of Adult

Impact of Intermittent Hypoxia on the Function of the Phagocytes

Start date: March 5, 2019
Phase:
Study type: Observational

Patients with treatment-naive obstructive sleep apnea (OSA) who need continuous positive airway pressure (CPAP) therapy on clinical basis are included as well as healthy controls without OSA. 15 cc peripheral venous blood is drawn on the date of diagnosis of OSA and 3-6 months after CPAP therapy. Granulocytes are harvested and tested for its function, such as phagocytosis, reactive oxygen species (ROS) production and bacteria-killing ability.