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Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

Primary Purpose

Obstructive Sleep Apnea of Adult

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

comprehensive rehabilitation

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea of Adult focused on measuring obstructive sleep apnea, oropharyngeal rehabilitation, cardiopulmonary rehabilitation

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Cheng Kung University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

We conducted a twice a week, 12-week-intervention of 'comprehensive rehabilitation'

We kept the patients for the waiting list until after completing baseline and 12-week measurement

Outcomes

Primary Outcome Measures

Apnea-hypopea-index

average apnea and hypopnea events per hour during sleep test

potential biomarkers of endothelial dysfunction

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

Secondary Outcome Measures

Oropharyngeal muscle function

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

Respiratory muscle function

PImax(mmH2O), PEmax(mmH2O)

Respiratory muscle function

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

Hear rate variability

time domain and frequency domain HRV

Full Information

NCT ID

NCT03940781

First Posted

January 10, 2019

Last Updated

May 6, 2019

Sponsor

National Cheng-Kung University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT03940781

Brief Title

Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

Official Title

Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Completed

Study Start Date

September 1, 2017 (Actual)

Primary Completion Date

February 28, 2019 (Actual)

Study Completion Date

March 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Cheng-Kung University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea of Adult

Keywords

obstructive sleep apnea, oropharyngeal rehabilitation, cardiopulmonary rehabilitation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

30 participants with moderate or severe OSA (AHI≥15) were randomized into intervention group (N=15) and control group (N=15).

Masking

ParticipantOutcomes Assessor

Masking Description

participants and assessors blinded

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intervention group

Arm Type

Experimental

Arm Description

We conducted a twice a week, 12-week-intervention of 'comprehensive rehabilitation'

Arm Title

control group

Arm Type

No Intervention

Arm Description

We kept the patients for the waiting list until after completing baseline and 12-week measurement

Intervention Type

Behavioral

Intervention Name(s)

comprehensive rehabilitation

Intervention Description

oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise

Primary Outcome Measure Information:

Title

Apnea-hypopea-index

Description

average apnea and hypopnea events per hour during sleep test

Time Frame

Change from Baseline Apnea-hypopnea-index at 12 weeks

Title

potential biomarkers of endothelial dysfunction

Description

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

Time Frame

at 12 weeks

Secondary Outcome Measure Information:

Title

Oropharyngeal muscle function

Description

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

Time Frame

at 12 weeks

Title

Respiratory muscle function

Description

PImax(mmH2O), PEmax(mmH2O)

Time Frame

at 12 weeks

Title

Respiratory muscle function

Description

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

Time Frame

at 12 weeks

Title

Hear rate variability

Description

time domain and frequency domain HRV

Time Frame

at 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chinghsia Hung, PhD

Organizational Affiliation

National Cheng-Kung University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Cheng Kung University Hospital

City

Tainan

ZIP/Postal Code

704

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

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Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

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