Clinical trial NCT03940781: Effects of Rehabilitation for Patients With Obstructive Sleep Apnea
Official title: Effects of Rehabilitation for Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea of Adult
Keywords: obstructive sleep apnea
oropharyngeal rehabilitation
cardiopulmonary rehabilitation
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2019-05-07
Enrollment: 33
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 30 participants with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15).
Primary purpose: TREATMENT

Brief summary: In previous review study, it was hypothesized that a comprehensive rehabilitation can combine both local pharyngeal muscle exercise and systemic cardiopulmonary rehabilitation for the OSA patients with oropharyngeal muscle dysfunction or ventilator drive instability. To develop a comprehensive rehabilitation model is of innovative care strategy in this study.

Detailed description: BACKGROUND: Obstructive sleep apnea (OSA) is a prevalent sleep-related breathing disorder, which was characterized by repetitive events of complete and partial obstructions of the upper airway. The pathogenesis of OSA is interacted by multiple factors, primarily including upper airway (UA) anatomic impairment, ventilatory drive instability, and oropharyngeal muscle dysfunction. However, studies have proven prior oropharyngeal exercise was designed for those OSA patients with oropharyngeal muscle dysfunction. Unlike prior oropharyngeal exercise, comprehensive rehabilitation should emphasize the cardiorespiratory regulation capability in addition to oropharyngeal function.

OBJECTIVES: Therefore, the purpose of this study is to explore both the clinical and biological effects of our comprehensive rehabilitation, we used PSG data as clinical effect and biomarker of inflammation expression as biological effect.

METHODS: Thirty subjects with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15). In intervention group, a 12-week-intervention of out-patient rehabilitation program included oropharyngeal muscle training, threshold respiratory muscle training, and therapeutic exercise.

ANTICIPATED OUTCOMES: The preliminary results would demonstrate promisingly clinical effects and biological effects of our comprehensive rehabilitation model. Therefore, the further studies should emphasize the methods to differentiate diagnosis for the indicated patients with oropharyngeal muscle dysfunction or ventilatory drive instability.

Eligibility criteria: Inclusion Criteria:

* Patients aged 35-65 with or without surgery had difficulty accepting or adhering CPAP

Exclusion Criteria:

* BMI\<32
* Smoking or alcoholism
* Severe allergic rhinitis
* Stroke history
* CVD
* Severe restricted or obstructive pulmonary disease
* Hypothyroidism
* DM or HTN without stable control
* Psychiatric disease
* Co-existing non-respiratory sleep disorders

Primary outcomes:
measure: Apnea-hypopea-index
timeFrame: Change from Baseline Apnea-hypopnea-index at 12 weeks
measure: potential biomarkers of endothelial dysfunction
timeFrame: at 12 weeks
Secondary outcomes:
measure: Oropharyngeal muscle function
timeFrame: at 12 weeks
measure: Respiratory muscle function
timeFrame: at 12 weeks
measure: Respiratory muscle function
timeFrame: at 12 weeks
measure: Hear rate variability
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Chinghsia Hung, PhD
role: PRINCIPAL_INVESTIGATOR
References: