Effects of Rehabilitation for Patients With Obstructive Sleep Apnea

NCT03940781 | Completed

• 1 other identifier: NCKUH-10802018
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea of Adult

Keywords

obstructive sleep apnea; oropharyngeal rehabilitation; cardiopulmonary rehabilitation

Outcome Measures

Primary Outcomes (2)

• Apnea-hypopea-index

  average apnea and hypopnea events per hour during sleep test

  Change from Baseline Apnea-hypopnea-index at 12 weeks

• potential biomarkers of endothelial dysfunction

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

  at 12 weeks

Secondary Outcomes (4)

• Oropharyngeal muscle function

  at 12 weeks

• Respiratory muscle function

  at 12 weeks

• Respiratory muscle function

  at 12 weeks

• Hear rate variability

  at 12 weeks

Study Arms (2)

intervention group

EXPERIMENTAL

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

Behavioral: comprehensive rehabilitation

control group

NO INTERVENTION

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

Interventions

comprehensive rehabilitation BEHAVIORAL

oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise

intervention group

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Chinghsia Hung, PhD

  National Cheng-Kung University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participants and assessors blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department chairman of physical therapy, College of Medicine, National Cheng Kung University

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

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: May 7, 2019
• Study Start: September 1, 2017
• Primary Completion: February 28, 2019
• Study Completion: March 22, 2019
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)