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OpenTrials
Completed

NCT Number: NCT03940781

Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

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.

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Key information

Conditions

Obstructive Sleep Apnea of Adult Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

comprehensive rehabilitation

Behavioral

oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise

Primary outcomes

  1. Apnea-hypopea-index

    Time frame: Change from Baseline Apnea-hypopnea-index at 12 weeks

    average apnea and hypopnea events per hour during sleep test

  2. potential biomarkers of endothelial dysfunction

    Time frame: at 12 weeks

    count of ICAM-1, VCAM-1, and NF-κB molecule in plasma serum (%)

Secondary outcomes

  1. Oropharyngeal muscle function

    Time frame: at 12 weeks

    myofunctional scale of genioglossus muscles, mastication muscles, and deglultition muscles

  2. Respiratory muscle function

    Time frame: at 12 weeks

    PImax(mmH2O), PEmax(mmH2O)

  3. Respiratory muscle function

    Time frame: at 12 weeks

    pulmonary function test (FVC%,FEV1%,FEF50%,FIF50%)

  4. Hear rate variability

    Time frame: at 12 weeks

    time domain and frequency domain HRV

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 7, 2019
Registry last updated
May 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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