Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

Obstructive Sleep Apnea of Adult Clinical Trial

Official title:

Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03940781
• Other study ID #: NCKUH-10802018
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: March 22, 2019

Study information

• Verified date: May 2019
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: March 22, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea of Adult
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• comprehensive rehabilitation
oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopea-index	average apnea and hypopnea events per hour during sleep test	Change from Baseline Apnea-hypopnea-index at 12 weeks
Primary	potential biomarkers of endothelial dysfunction	count of ICAM-1, VCAM-1, and NF-?B molecule in plasma serum (%)	at 12 weeks
Secondary	Oropharyngeal muscle function	myofunctional scale of genioglossus muscles, mastication muscles, and deglultition muscles	at 12 weeks
Secondary	Respiratory muscle function	PImax(mmH2O), PEmax(mmH2O)	at 12 weeks
Secondary	Respiratory muscle function	pulmonary function test (FVC%,FEV1%,FEF50%,FIF50%)	at 12 weeks
Secondary	Hear rate variability	time domain and frequency domain HRV	at 12 weeks