Initiation of therapy for obstructive sleep apnea syndrome: a randomized comparison of outcomes of telemetry-supported home-based vs. sleep lab-based therapy initiation

Abstract Purpose Diagnosis and treatment of obstructive sleep apnea are traditionally performed in sleep laboratories with polysomnography (PSG) and are associated with significant waiting times for patients and high cost. We investigated if initiation of auto-titrating CPAP (APAP) treatment at home in patients with obstructive sleep apnea (OSA) and subsequent telemonitoring by a homecare provider would be non-inferior to in-lab management with diagnostic PSG, subsequent in-lab APAP initiation, and standard follow-up regarding compliance and disease-specific quality of life. Methods This randomized, open-label, single-center study was conducted in Germany. Screening occurred between December 2013 and November 2015. Eligible patients with moderate-to-severe OSA documented by polygraphy (PG) were randomized to home management or standard care. All patients were managed by certified sleep physicians. The home management group received APAP therapy at home, followed by telemonitoring. The control group received a diagnostic PSG, followed by therapy initiation in the sleep laboratory. The primary endpoint was therapy compliance, measured as average APAP usage after 6 months. Results The intention-to-treat population (ITT) included 224 patients (110 home therapy, 114 controls); the per-protocol population (PP) included 182 patients with 6-month device usage data (89 home therapy, 93 controls). In the PP analysis, mean APAP usage at 6 months was not different in the home therapy and control groups (4.38 ± 2.04 vs. 4.32 ± 2.28, p = 0.845). The pre-specified non-inferiority margin (NIM) of 0.3 h/day was not achieved (p = 0.130); statistical significance was achieved in a post hoc analysis when NIM was set at 0.5 h/day (p < 0.05). Time to APAP initiation was significantly shorter in the home therapy group (7.6 ± 7.2 vs. 46.1 ± 23.8 days; p < 0.0001). Conclusion Use of a home-based telemonitoring strategy for initiation of APAP in selected patients with OSA managed by sleep physicians is feasible, appears to be non-inferior to standard sleep laboratory procedures, and facilitates faster access to therapy.

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Effect of Cooling Irrigating Saline in Tongue Base Ablation in Obstructive Sleep Apnea

OTO Open ◽

10.1177/2473974x21989599 ◽

2021 ◽

Vol 5 (1) ◽

pp. 2473974X2198959

Author(s):

Ahmed Yassin Bahgat

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Controlled Trial ◽

Tongue Base ◽

Control Group ◽

University Hospitals ◽

Energy Field ◽

Obstructive Sleep ◽

Prospective Randomized Controlled Trial ◽

Significant Difference

Objective Plasma is formed by creating a high-density energy field within an electrically conductive fluid such as saline. Sometimes ablated bits of tissue get stuck between the electrodes of the wand, obstructing the suction channel. The purpose of this study is to investigate the effect of cooling the irrigating saline during ablation of the hypertrophied tongue base in patients with obstructive sleep apnea. Study Design Prospective randomized controlled trial. Setting An otorhinolaryngology department in Main University hospitals. Methods Sixty adult patients with obstructive sleep apnea and tongue base hypertrophy underwent tongue base ablation surgery. Patients were randomly divided into 2 groups of 30 patients each: cooled saline and room temperature saline. The Coblation wand used was the EVac 70 Xtra HP (Smith & Nephew). Results In this study, a significant difference in operative time (mean ± SD) was seen between groups: 21.2 ± 5.5 minutes in the cold group and 47 ± 9.5 minutes in the control group ( P = .001). The wands in the cold group did not obstruct, while all the wands in the control group were obstructed by tissue clogs with variable degrees, hence wasting more time to clean the wands’ tips. Conclusion Cooling the irrigating saline overcame the problem of wand clogs, and the wand tip did not occlude at all during the procedures, thus saving time lost in wand cleaning and demonstrating a faster and safer surgical procedure. Further studies are needed to identify the hemostatic effect of the cooled saline over the regular one.

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Evaluation of corneal endothelium using specular microscopy in patients with obstructive sleep apnea syndrome

European Journal of Ophthalmology ◽

10.1177/11206721211006577 ◽

2021 ◽

pp. 112067212110065

Author(s):

Murat Serkan Songur ◽

Yavuz Selim İntepe ◽

Seray Aslan Bayhan ◽

Hasan Ali Bayhan ◽

Ender Şahin ◽

...

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Coefficient Of Variation ◽

Corneal Endothelium ◽

Corneal Thickness ◽

Sleep Apnea Syndrome ◽

Control Group ◽

Specular Microscopy ◽

Obstructive Sleep ◽

Apnea Syndrome

Purpose: In the present study we evaluate the corneal endothelium using specular microscopy in patients with obstructive sleep apnea syndrome (OSAS). Methods: The study included a total of 100 patients including 35 patients with mild OSAS, 34 patients with moderate OSAS and 31 patients with severe OSAS, and the right eyes of 30 patients as a control group. Patients were examined to exclude the possibility of ocular diseases. Cellular density in the cornea epithelium (cell/mm2), corneal thickness (µ), percentage of hexagonal cells (%) and the coefficient of variation were evaluated using a specular microscope. Results: Corneal thickness was significantly decreased in all OSAS groups when compared to the control group ( p = 0.002), while no significant difference was identified among the OSAS groups. The corneal endothelial cell density, percentage of hexagonal cells and coefficient of variation were significantly different between the OSAS groups and the control group ( p < 0.001). Conclusion: More significant impairments were noted in the corneal endothelium of the patients in the OSAS group than in the control group, and specular microscopy is in valuable in the follow-up and treatment of such patients.

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The effect of 4-h versus 6-h time restricted feeding on sleep quality, duration, insomnia severity and obstructive sleep apnea in adults with obesity

Nutrition and Health ◽

10.1177/02601060211002347 ◽

2021 ◽

pp. 026010602110023

Author(s):

Sofia Cienfuegos ◽

Kelsey Gabel ◽

Faiza Kalam ◽

Mark Ezpeleta ◽

Vicky Pavlou ◽

...

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Sleep Quality ◽

Sleep Onset ◽

Control Group ◽

Sleep Onset Latency ◽

Restricted Feeding ◽

Wake Time ◽

Obstructive Sleep ◽

Insomnia Severity

Background: Time restricted feeding (TRF) involves deliberately restricting the times during which energy is ingested. Preliminary findings suggest that 8–10-h TRF improves sleep. However, the effects of shorter TRF windows (4–6 h) on sleep, remain unknown. Aims: This study compared the effects of 4-h versus 6-h TRF on sleep quality, duration, insomnia severity and the risk of obstructive sleep apnea. Methods: Adults with obesity ( n = 49) were randomized into one of three groups: 4-h TRF (eating only between 3 and 7 p.m.), 6-h TRF (eating only between 1 and 7 p.m.), or a control group (no meal timing restrictions) for 8 weeks. Results: After 8 weeks, body weight decreased ( p < 0.001) similarly by 4-h TRF (–3.9 ± 0.4 kg) and 6-h TRF (–3.4 ± 0.4 kg), versus controls. Sleep quality, measured by the Pittsburgh Sleep Quality Index (PSQI), did not change by 4-h TRF (baseline: 5.9 ± 0.7; week 8: 4.8 ± 0.6) or 6-h TRF (baseline: 6.4 ± 0.8; week 8: 5.3 ± 0.9), versus controls. Wake time, bedtime, sleep duration and sleep onset latency also remained unchanged. Insomnia severity did not change by 4-h TRF (baseline: 4.4 ± 1.0; week 8: 4.7 ± 0.9) or 6-h TRF (baseline: 8.3 ± 1.2; week 8: 5.5 ± 1.1), versus controls. Percent of participants reporting obstructive sleep apnea symptoms did not change by 4-h TRF (baseline: 44%; week 8: 25%) or 6-h TRF (baseline: 47%; week 8: 20%), versus controls. Conclusion: These findings suggest that 4- and 6-h TRF have no effect on sleep quality, duration, insomnia severity, or the risk of obstructive sleep apnea.

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Reliability of Holter Oximetry for Home Sleep Apnea Testing

Otolaryngology ◽

10.1016/j.otohns.2008.05.269 ◽

2008 ◽

Vol 139 (2_suppl) ◽

pp. P83-P84 ◽

Cited By ~ 1

Author(s):

Jordan C Stern ◽

Conor Heneghan ◽

Redmond Shouldice

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Apnea Hypopnea Index ◽

Patients Âgés ◽

Home Testing ◽

Obstructive Sleep ◽

Adults And Children ◽

Home Sleep Apnea Testing ◽

A Prospective Study ◽

At Home

Objective To test the reliability of the Holter Oximeter for home testing of obstructive sleep apnea. Previous reports have shown a 96% correlation with simultaneous polysomnography and Holter Oximetry in the sleep laboratory. This study was designed to measure reliability of data obtained at home, as well as to obtain information from patients regarding comfort of the device. Methods A prospective study of 120 consecutive patients (ages 5 to 85) presenting to an otolaryngology practice during a 4-month period with complaints of snoring or sleep apnea symptoms. Device: The Holter Oximeter produces an apnea hypopnea index (AHI) based on an automated processing method of a continuous electrocardiogram and pulse oximeter. The reliability of the test was determined by the number of tests completed without interruption due to patient discomfort, electrode or device failure. Results There was 97% data recovery from the home testing device. Data failure was due to faulty memory cards in the device or surface electrode failure. All patients tolerated wearing the device at home, and there were no voluntary interruptions of the tests by patients. On a discomfort scale of 0 to 10 (0: no discomfort and 10: maximal discomfort), the average discomfort score was 2. Conclusions Holter Oximetry represents a new, easy to use, and reliable device for the home diagnosis of obstructive sleep apnea. It can also be used to measure outcomes for the surgical and non-surgical treatment of obstructive sleep apnea in adults and children.

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Evaluation of tongue/mandible volume ratio in children with obstructive sleep apnea

Dental Press Journal of Orthodontics ◽

10.1590/2177-6709.23.4.072-078.oar ◽

2018 ◽

Vol 23 (4) ◽

pp. 72-78 ◽

Cited By ~ 3

Author(s):

Kavita Hotwani ◽

Krishna Sharma ◽

Arpan Jaiswal

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Soft Tissue ◽

Volume Ratio ◽

Radiology Department ◽

Control Group ◽

Mr Images ◽

Early Screening ◽

Obstructive Sleep ◽

Tongue Volume

ABSTRACT Objective: The present study was an attempt to investigate tongue/mandible volume ratio in children, using volumetric magnetic resonance imaging (MRI) for early screening and to aid in treatment planning. Methods: Volumetric evaluation of tongue volume/mandible volume ratio (TV/MV ratio) in children with obstructive sleep apnea (OSA) using MRI was carried out retrospectively on available DICOM MR images of children in the age group of 10-14 years. MRI image records of patients diagnosed with OSA were obtained from interventional radiology department records, at Sharad Pawar Dental College and Hospital (Datta Meghe Institute of Medical Sciences, Nagpur/India). The age, gender, height and weight of the subjects were retrieved from patient database and registered. For the control group, available MRI images of healthy subjects without OSA were retrieved. Body mass index (BMI) was also calculated using the height and the weight present in the records. Measurements from MR images were made using DICOM image processing software. Soft tissue and bony structure segmentation was performed by manual tracing. The tongue volume and mandible volume were directly computed using the software. The tongue volume/mandible volume ratio (TV/MV) was generated using the above values and expressed as a percentage for both groups. Results: The difference between OSA group and control group with respect to TV/MV ratio was found to be highly significant at 0.05 level of significance. There was no significant correlation between BMI and TV/MV ratio in OSA group (p= 0.451) as well as in control group (p= 0.094). Conclusion: TV/MV ratio may be an appropriate variable to evaluate the risk of OSA, representing the balance between skeletal morphology and soft tissue morphology in craniofacial complex.

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Endothelial Function and Arterial Stiffness Should Be Measured to Comprehensively Assess Obstructive Sleep Apnea in Clinical Practice

Frontiers in Cardiovascular Medicine ◽

10.3389/fcvm.2021.716916 ◽

2021 ◽

Vol 8 ◽

Author(s):

Jinmei Luo ◽

Xiaona Wang ◽

Zijian Guo ◽

Yi Xiao ◽

Wenhao Cao ◽

...

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Arterial Stiffness ◽

Endothelial Function ◽

Augmentation Index ◽

Reactive Hyperemia ◽

Control Group ◽

Apnea Hypopnea Index ◽

Obstructive Sleep ◽

Tnf Α

Objective: An effective clinical tool to assess endothelial function and arterial stiffness in patients with obstructive sleep apnea (OSA) is lacking. This study evaluated the clinical significance of subclinical markers for OSA management in males without serious complications.Patients/Methods: Males without serious complications were consecutively recruited. Clinical data, biomarker tests, reactive hyperemia index (RHI), and augmentation index at 75 beats/min (AIx75) measured by peripheral arterial tonometry were collected. An apnea hypopnea index (AHI) cutoff of ≥15 events/h divided the patients into two groups.Results: Of the 75 subjects, 42 had an AHI ≥15 events/h. Patients with an AHI ≥15 events/h had higher high-sensitivity C-reactive protein, tumor necrosis factor-alpha (TNF-α), vascular endothelial growth factor, and AIx75 values than the control group but no statistical difference in RHI was observed. After controlling for confounders, TNF-α was negatively correlated with the average oxygen saturation (r = −0.258, P = 0.043). RHI was correlated with the rapid eye movement (REM) stage percentage (r = 0.306, P = 0.016) but not with AHI (P > 0.05). AIx75 was positively correlated with the arousal index (r = 0.289, P = 0.023) but not with AHI (r = 0.248, P = 0.052).Conclusions: In males with OSA without severe complications, TNF-α and AIx75 are independently related to OSA. The role of RHI in OSA management requires further elucidation. These markers combined can comprehensively evaluate OSA patients to provide more evidence for the primary prevention of coronary heart disease and treatment response assessment.

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Home-based Screening for Obstructive Sleep Apnea in Children

US Respiratory & Pulmonary Diseases ◽

10.17925/usprd.2020.5.1.38 ◽

2020 ◽

Vol 5 (1) ◽

pp. 38

Author(s):

Dylan Bertoni ◽

Amal Isaiah ◽

◽

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Home Based ◽

Obstructive Sleep

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Cardiorespiratory Polygraphy for Detection of Obstructive Sleep Apnea in Patients With Atrial Fibrillation

Frontiers in Cardiovascular Medicine ◽

10.3389/fcvm.2021.758548 ◽

2021 ◽

Vol 8 ◽

Author(s):

Michiel Delesie ◽

Lieselotte Knaepen ◽

Johan Verbraecken ◽

Karolien Weytjens ◽

Paul Dendale ◽

...

Keyword(s):

Atrial Fibrillation ◽

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Screening Tool ◽

Area Under The Curve ◽

Screening Tools ◽

Apnea Hypopnea Index ◽

Automated Algorithm ◽

Obstructive Sleep ◽

At Home

Background: Obstructive sleep apnea (OSA) is a modifiable risk factor of atrial fibrillation (AF) but is underdiagnosed in these patients due to absence of good OSA screening pathways. Polysomnography (PSG) is the gold standard for diagnosing OSA but too resource-intensive as a screening tool. We explored whether cardiorespiratory polygraphy (PG) devices using an automated algorithm for Apnea-Hypopnea Index (AHI) determination can meet the requirements of a good screening tool in AF patients.Methods: This prospective study validated the performance of three PGs [ApneaLink Air (ALA), SOMNOtouch RESP (STR) and SpiderSAS (SpS)] in consecutive AF patients who were referred for PSG evaluation. Patients wore one of the three PGs simultaneously with PSG, and a different PG during each of three consecutive nights at home. Severity of OSA was classified according to the AHI during PSG (<5 = no OSA, 5–14 = mild, 15–30 = moderate, >30 = severe).Results: Of the 100 included AF patients, PSG diagnosed at least moderate in 69% and severe OSA in 33%. Successful PG execution at home was obtained in 79.1, 80.2 and 86.8% of patients with the ALA, STR and SpS, respectively. For the detection of clinically relevant OSA (AHI ≥ 15), an area under the curve of 0.802, 0.772 and 0.803 was calculated for the ALA, STR and SpS, respectively.Conclusions: This study indicates that home-worn PGs with an automated AHI algorithm can be used as OSA screening tools in AF patients. Based on an appropriate AHI cut-off value for each PG, the device can guide referral for definite PSG diagnosis.

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Cost-Effectiveness Analysis of Positive Airway Pressure in Patient with Obstructive Sleep Apnea

Journal of Rhinology ◽

10.18787/jr.2021.00357 ◽

2021 ◽

Vol 28 (2) ◽

pp. 94-101

Author(s):

Hansol Kim ◽

Jin Kook Kim ◽

Jae Hoon Cho

Keyword(s):

Obstructive Sleep Apnea ◽

Cost Effectiveness ◽

Sleep Apnea ◽

Treatment Group ◽

Airway Pressure ◽

Positive Airway Pressure ◽

Control Group ◽

Medical Expenses ◽

Effectiveness Analysis ◽

Obstructive Sleep

Background and Objectives: Positive airway pressure (PAP) is effective at reducing the number of complications in patients with obstructive sleep apnea (OSA). To the best of our knowledge, no cost-effectiveness analysis of PAP has been conducted in Korea. Subjects and Method: We classified subjects into two groups, those with moderate-to-severe OSA who used PAP after polysomnography (PAP treatment group) and those who did not receive a diagnosis and treatment (control group), and compared their medical expenses over a period of 10 years. The incidence rate of common complications and accidents (coronary heart disease, heart failure, stroke, depression, diabetes, vehicular accidents, and work-related accidents) with or without PAP was adopted through a literature review. The average medical expenses for treating each complication and accident were found by searching several databases. The analysis consisted of a payer’s perspective and a societal perspective. Results: The incidence of all complications was higher in the control group than in the PAP treatment group. However, since the absolute incidence rate was not high in either group and medical expenses in Korea are low, the expected treatment cost was not high. In contrast, the PAP rental fee was relatively high. To obtain 1 unit of disability-adjusted life year, it costs 40,873,288 won from the payer’s perspective and 31,791,810 won from the societal perspective. Conclusion: PAP treatment reduces patient complications and extends their lifespan, but costs must be considered.

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Gastroesophageal Reflux Disease: A Cause for Eustachian Tube Dysfunction in Obstructive Sleep Apnea

Ear Nose & Throat Journal ◽

10.1177/0145561320931219 ◽

2020 ◽

pp. 014556132093121

Author(s):

Suying Yan ◽

Yongxiang Wei ◽

Xiaojun Zhan ◽

Linyin Yao ◽

Xiping Li ◽

...

Keyword(s):

Obstructive Sleep Apnea ◽

Sleep Apnea ◽

Gastroesophageal Reflux Disease ◽

Gastroesophageal Reflux ◽

Eustachian Tube ◽

Reflux Disease ◽

Eustachian Tube Dysfunction ◽

Control Group ◽

Obstructive Sleep ◽

Tube Dysfunction

Objectives: To explore the effect of gastroesophageal reflux disease (GERD) on Eustachian tube function in patients with obstructive sleep apnea (OSA). Methods: This was a cross-sectional study. The patients were divided into 4 groups according to OSA and GERD: OSA+GERD group; OSA-only group; GERD-only group; and normal control group. Results: There were no differences among the 4 groups regarding age, sex, smoking history, and alcohol history (all P > .05). The patients in the OSA and OSA+GERD groups had a significantly larger body mass index than those in the control and GERD-only groups (all P < .05). The proportions of patients with abnormal ETS-7 and ETD-Q results were higher in the GERD and OSA+GERD groups compared to the control group ( P < .008). There were no significant differences in ETS-7 and ETD-Q between the control and the OSA-only groups ( P > .008). The multivariable analysis showed that only GERD was independently associated with abnormal ETS-7 results (odds ratio = 3.090, 95% CI: 1.332-7.169, P = .009). Conclusion: Given the high concomitance rate in patients with OSA, GERD might be an important association factor of Eustachian tube dysfunction in patients with OSA.

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