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Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

  • Clinicaltrials.gov identifier

    NCT03940781

  • Recruitment Status

    Completed

  • First Posted

    May 7, 2019

  • Last update posted

    May 7, 2019

Study Description

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.

  • Condition or Disease:Obstructive Sleep Apnea of Adult
  • Intervention/Treatment: Behavioral: comprehensive rehabilitation
  • Phase: N/A

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.

Study Design

  • Study Type: Interventional
  • Actual Enrollment: 33 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Intervention Model Description: 30 participants with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15).
  • Masking: Double (Participant, Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Effects of Rehabilitation for Patients With Obstructive Sleep Apnea
  • Actual Study Start Date: September 2017
  • Actual Primary Completion Date: February 2019
  • Actual Study Completion Date: March 2019

Arms and interventions

Arm Intervention/treatment
Experimental: intervention group
We conducted a twice a week, 12-week-intervention of 'comprehensive rehabilitation'
Behavioral: comprehensive rehabilitation
oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise

Outcome Measures

  • Primary Outcome Measures: 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 Outcome Measures: 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

Eligibility Criteria

  • Ages Eligible for Study: 35 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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

Contacts and Locations

Contacts

Locations

Taiwan
National Cheng Kung University Hospital
Tainan

Sponsors and Collaborators

National Cheng-Kung University Hospital

Investigators

Principal Investigator: Chinghsia Hung, PhD National Cheng-Kung University Hospital

More Information

  • Responsible Party: National Cheng-Kung University Hospital
  • ClinicalTrials.gov Identifier: NCT03940781 History of Changes
  • Other Study ID Numbers: NCKUH-10802018
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: May 7, 2019
  • Last Verified: May 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by National Cheng-Kung University Hospital: obstructive sleep apnea
    oropharyngeal rehabilitation
    cardiopulmonary rehabilitation
  • Additional relevant MeSH terms: Apnea
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive