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Sleep Apnea, Obstructive clinical trials

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NCT ID: NCT03189173 Active, not recruiting - Clinical trials for Obstructive Sleep Apnea

Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea

Start date: September 6, 2017
Phase: Phase 2
Study type: Interventional

The current study combines two treatments for obstructive sleep apnea (OSA), oral appliances and supplemental inspired oxygen. The following aims will be tested: Aim 1. To determine whether supplemental inspired oxygen further reduces OSA severity (apnea-hypopnea index) in patients using an oral appliance. Aim 2. To determine whether baseline OSA phenotypes can predict the efficacy of oral appliances versus supplemental oxygen versus both treatments in combination. We will test whether responders to oral appliances have distinct pathophysiological characteristics compared with oxygen responders.

NCT ID: NCT03113461 Active, not recruiting - Clinical trials for Mild Cognitive Impairment

MCI: CPAP Treatment of OSA (Memories2)

MCI:OSA
Start date: January 19, 2018
Phase: N/A
Study type: Interventional

The purpose of this project is to determine whether obstructive sleep apnea (OSA) treatment with positive airway pressure therapy (CPAP) can delay the progression of cognitive impairment in patients with amnestic Mild Cognitive Impairment (MCI) as measured by cognitive testing, and brain magnetic resonance imaging (MRI) scans. Study participants will be assessed at baseline, six-month (cognitive tests only) and one-year follow-up.

NCT ID: NCT03109210 Active, not recruiting - Clinical trials for Sleep Apnea, Obstructive

Therapist-Directed VS Online Therapy for Insomnia Co-Occuring With Sleep Apnea

Start date: April 15, 2017
Phase: N/A
Study type: Interventional

This two-site randomized clinical trial will investigate and compare three treatments for insomnia in patients who have been diagnosed with and treated for sleep apnea: online cognitive behavioral therapy (OCBT), therapist-directed cognitive behavioral therapy (TCBT), and standard clinical care. 384 patients will be recruited and will attend up to 15 visits over 10 months. Visits will include baseline assessment, treatment visits, and post-treatment follow-up visits. Visits will involve completion of questionnaires, meeting with therapists, and a physical exam.

NCT ID: NCT03043716 Active, not recruiting - Clinical trials for Obstructive Sleep Apnea

Long-term Observation of PAP-therapy With Telemonitoring: Telemedicine Registry TelePAP

TelePAP
Start date: August 1, 2017
Phase:
Study type: Observational [Patient Registry]

Telemonitoring for Positive Airway Pressure (PAP) therapy might help to establish and maintain long-term therapy adherence and thus support the beneficial effects of PAP therapy on long-term outcomes.

NCT ID: NCT03018912 Active, not recruiting - Insomnia Clinical Trials

Validating the Use of a Subjectively Reported Sleep Vital Sign

SSVS
Start date: October 22, 2018
Phase: N/A
Study type: Interventional

Sleep disorders are commonly under-recognized in the primary care setting and available screening tools are often are limited. The study inestigators hypothesize that the use of a novel subjective sleep vital sign (VS) will improve recognition of patients with sleep disorders and can be utilized to track outcomes to sleep therapy.

NCT ID: NCT02979184 Active, not recruiting - Lymphedema Clinical Trials

Prevalence of Obstructive Sleep Apnea (OSA) in Patients With Lymphedema, Admitted for Intensive Decongestive Physiotherapy

LYMPHOS
Start date: November 2016
Phase: N/A
Study type: Interventional

Rehabilitation results in a decrease of the perimeters of the limb with lymphedema by a decrease in the amount of liquid of the affected limb, with movement of the intracellular liquid towards the trunk and the neck then into the jugular-subclavian confluence, the superior vena cava and right atrium without modification of extracellular fluid. No study have evaluated the prevalence of sleep apnea syndrome in this population and the effect of this treatment on sleep apnea syndrome.

NCT ID: NCT02953028 Active, not recruiting - Clinical trials for Sleep Apnea, Obstructive

Obstructive Sleep Apnea - Patient Specific Factors, Success Rate and Compliance

Start date: October 2014
Phase: N/A
Study type: Interventional

Obstructive sleep apnea (OSA) is a condition where the patient's breathing cease during sleep due to collapse of the oro-pharynx. The consequences are reduced quality of sleep, increased risk for developing cardiovascular disease and increased risk of accidents caused by daytime sleepiness. Among Norwegians 30-65 yrs, the prevalence of OSA are estimated to 16%. The golden standard in OSA-treatment is Continuous Positive Airway Pressure (CPAP). This is effective and must be used for life. However, CPAP-treatment might be uncomfortable for the patient, with poor compliance as a result. An alternative is Mandibular Advancing Splints (MAS), which is perceived as less troublesome and may initiate higher compliance. Through mapping of patient characteristics, the researchers investigate which patient-type benefits most from two different treatment-devices. The aim of the study is to assess how the MAS treatment differ from the CPAP treatment in respect to efficacy, compliance and impact on health related quality of life among patient diagnosed with mild/moderate OSA. All OSA patients referred to the Ear- Nose- Throat-department (ENT) at University Hospital, Northern-Norway (UNN) and St.Olavs Hospital were invited to participate in the study. The sample size at completion of the study should be 140 patients. Participants in the trial were randomly allocated to the two treatment groups, and assessed after 4 and 12 months of treatment. Data were collected through anamnesis, clinical examination, clinical photos, radiographs and questionnaires concerning general health related quality of life (SF36), oral health, cognitive aspects (HADS), sleep quality (PSQI), daytime sleepiness (Epworth's Sleepiness scale) and compliance.

NCT ID: NCT02948894 Active, not recruiting - Heart Failure Clinical Trials

Mandibular Advancement Device for Treatment of Obstructive Sleep Apnea and Its Impact on Cardiac Remodeling

MOSAIC
Start date: May 1, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Primary aim: The MOSAIC trial aims to assess the impact of a mandibular advancement device (MAD) on Apnea-Hypopnea Index (AHI) in Asian patients with Heart Failure with reduced Ejection Fraction (HFrEF) and obstructive sleep apnea (OSA). The investigators hypothesize that the AHI was 60% lower after 3-month treatment with MAD than with sham MAD. Secondary aims: The investigators also aim to determine i. the interaction between ethnicity (Chinese, Malay, Indians) and the effects of MAD in lowering AHI; ii. the effect of MAD on cardiac remodeling (LVEDVI assessed by cardiac magnetic resonance imaging [CMR]); iii. the characteristic craniofacial skeletal anatomy (using coned beam computed tomography [CT]) associated with OSA in Asian patients with HFrEF; iv. the association between self-reported adherence to MAD and cardiac remodeling; v. the effects of MAD on biomarkers of HF (N-terminal pro-B-type natriuretic peptide [NT-proBNP],high sensitivity cardiac troponin T [hs cTnT], high-sensitivity C-reactive protein [hs-CRP], and ST2); Rationale: OSA is associated with incident HF. The investigators will study Asian patients because a body of evidence suggests mechanisms for OSA differ between Asians and Caucasians. While obesity is the major contributing factor in Caucasians, craniofacial skeletal anatomy (short mandible, maxilla, and cranial base and a large mandibular volume) plays an important role in the development of OSA among Asians. Using cone beam CT, it has been shown that Asians have shorter mandibular, maxillary, and cranial base lengths and a greater mandibular volume compared with Caucasians. Using a MAD to adjust maxillary-mandibular juxta-positioning to maintain a patent airway may be an ethnic-specific approach to treat OSA in Asians.

NCT ID: NCT02917876 Active, not recruiting - Obesity Clinical Trials

Predictors of De-novo Development of Obstructive Sleep Apnea in Pregnancy

Predictors
Start date: November 2016
Phase:
Study type: Observational

This study seeks to understand the physical, physiologic and biologic features that predispose a woman to the development of obstructive sleep apnea once they are exposed to the cardiopulmonary and metabolic physiological changes of pregnancy. Knowing these specific predictive factors can help identify a population at risk and guide clinicians to develop suitable targeting screening strategies.

NCT ID: NCT02907398 Active, not recruiting - Clinical trials for Obstructive Sleep Apnea

Adherence and Outcome of Upper Airway Stimulation (UAS) for OSA International Registry

Start date: October 19, 2016
Phase:
Study type: Observational [Patient Registry]

Inspire intends to conduct this registry to: 1) collect Inspire therapy clinical evidence in the clinical practice setting; 2) collect additional information on the effectiveness, use and safety in the commercial setting; and 3) engage physician customers to report the collective outcome within a group of properly trained programs that utilize Inspire therapy on a regular basis. In addition, a sub-study will be conducted under this Registry at a limited number of Registry centers and will include a cohort of Registry patients and a cohort of patients who have not received the Inspire therapy device due to denial of insurance coverage. The two sub-study cohorts' quality of life and AHI data will be compared.