Mobile Health Pulmonary Rehabilitation Compared to a Center-Based Program for Cost-Effectiveness and Effects on Exercise Capacity, Health Status, and Quality of Life in People With Chronic Obstructive Pulmonary Disease: A Protocol for a Randomized Controlled Trial.

OBJECTIVE: The use of digital health is a novel way to improve access to comprehensive pulmonary rehabilitation for people with chronic obstructive pulmonary disease (COPD). This study aims to determine if a home-based pulmonary rehabilitation program supported by mobile health (mHealth) technology is equivalent to center-based pulmonary rehabilitation in terms of improvements in exercise capacity and health status in people with COPD. METHODS: This study is a prospective, multicenter, equivalence randomized controlled trial (RCT) with intention-to-treat analysis. A hundred participants with COPD will be recruited from 5 pulmonary rehabilitation programs. Following randomization, participants will be assigned in a concealed manner to receive either home-based pulmonary rehabilitation supported by mHealth or center-based pulmonary rehabilitation. Both programs will be 8 weeks and will include progressive exercise training, disease management education, self-management support, and supervision by a physical therapist. Co-primary outcome measures will be the 6-Minute Walk Test and the COPD Assessment Test. Secondary outcome measures will include the St George's Respiratory Questionnaire, the EuroQol 5 Dimension 5 Level, the modified Medical Research Council dyspnea scale, the 1-minute sit-to-stand test, the 5 times sit-to-stand test, the Hospital Anxiety and Depression Scale, daily physical activity levels, health care utilization, and costs. Outcomes will be measured at baseline and at the end of the intervention. Participant experience will be assessed through semi-structured interviews at the end of the intervention. Utilization of health care and costs will be measured again after 12 months. IMPACT: This study will be the first rigorous RCT to examine the effects of a home-based pulmonary rehabilitation program supported by mHealth technology that includes comprehensive clinical outcome evaluation, assessment of daily physical activity, a health economic analysis, and qualitative analysis. If findings demonstrate that there is equivalence in clinical outcomes, that the mHealth program costs the least amount (and is thus cost-effective), and that the mHealth program is acceptable to participants, such programs should be widely implemented to improve access to pulmonary rehabilitation.

Qualitative assessment of awake nasopharyngoscopy for prediction of oral appliance treatment response in obstructive sleep apnoea.

PURPOSE: Clinical methods to identify responders to oral appliance (OA) therapy for obstructive sleep apnoea (OSA) are needed. Awake nasopharyngoscopy during mandibular advancement, with image capture and subsequent processing and analysis, may predict treatment response. A qualitative assessment of awake nasopharyngoscopy would be simpler for clinical practice. We aimed to determine if a qualitative classification system of nasopharyngoscopic observations reflects treatment response. METHODS: OSA patients were recruited for treatment with a customised two-piece OA. A custom scoring sheet was used to record observations of the pharyngeal airway (velopharynx, oropharynx, hypopharynx) during supine nasopharyngoscopy in response to mandibular advancement and performance of the Müller manoeuvre. Qualitative scores for degree (< 25%, 25-50%, 50-75%, > 75%), collapse pattern (concentric, anteroposterior, lateral) and diameter change (uniform, anteroposterior, lateral) were recorded. Treatment outcome was confirmed by polysomnography after a titration period of 14.6 ± 9.8 weeks. Treatment response was defined as (1) Treatment AHI < 5, (2) Treatment AHI < 10 plus > 50% AHI reduction and (3) > 50% AHI reduction. RESULTS: Eighty OSA patients (53.8% male) underwent nasopharyngoscopy. The most common naspharyngoscopic observation with mandibular advancement was a small (< 50%) increase in velopharyngeal lateral diameter (37.5%). The majority of subjects (72.5%) were recorded as having > 75% velopharyngeal collapse on performance of the Müller manoeuvre. Mandibular advancement reduced the observed level of pharyngeal collapse at all three pharyngeal regions (p < 0.001). None of the nasopharyngoscopic qualitative scores differed between responder and non-responder groups. CONCLUSION: Qualitative assessment of awake nasopharyngoscopy appears useful for assessing the effect of mandibular advancement on upper airway collapsibility. However, it is not sensitive enough to predict oral appliance treatment outcome.

Three-dimensional assessment of anatomical balance and oral appliance treatment outcome in obstructive sleep apnoea.

PURPOSE: Mandibular advancement splints (MAS) are an effective treatment for obstructive sleep apnoea (OSA). However, MAS are not equally efficacious across all patients and the reasons are not well understood. Craniofacial and upper airway structure individually influence MAS response. We aimed to assess anatomical balance, defined as the ratio of upper airway soft tissue (ST) volume to maxillomandibular enclosure volume, between MAS treatment responders and non-responders. METHODS: OSA patients (apnoea-hypopnea index (AHI) >10 h(-1)) were recruited for MAS treatment. Magnetic resonance imaging of the upper airway was performed during wakefulness without and with MAS in situ. Images were processed for volumetric analysis of upper airway soft tissues (tongue, soft palate, paraphayrngeal fat pads and lateral pharyngeal walls) and three-dimensional cephalometry to acquire intra-mandibular space area (IMA) and total maxillomandibular (Mm) volume. Anatomical balance ratios were compared between MAS treatment responders (AHI <10 h(-1) + 50 % reduction) and non-responders. RESULTS: Image analysis was completed in 69 patients (68 % male, age 50.5 ± 10.1 years, BMI 29.6 ± 5.0 kgm(2), AHI 27.0 ± 14.7 h(-1)) including 36 responders. Soft tissue volumes did not differ between MAS responders and non-responders. Non-responders had increased ST/IMA compared to responders (4.9 ± 0.6 vs. 4.6 ± 0.6, p = 0.031). In multivariate logistic regression with AHI and BMI, ST/IMA was the only predictive variable (p = 0.036, ROC AUC 0.7). However, changes in ST/Mm did not directly relate to treatment response. CONCLUSIONS: Anatomical imbalance assessed by intra-mandibular space area was associated with poor MAS treatment response. However, changes in anatomical balance with mandibular advancement did not reflect treatment outcome as static imaging may not adequately capture improvements in upper airway function.