The Impact of Sleep Apnea Treatment on Physiology Traits in Chinese Patients With Obstructive Sleep Apnea

July 26, 2017 updated by: YANRU LI, Beijing Tongren Hospital

The prevalence of OSA is 3.5~4.6% in Chinese adults. OSA leads to repetitive hypoxemia, hypercapnia, and arousal from sleep and is an independent risk factor for hypertension, stroke, coronary artery disease and congestive heart failure. CPAP is the first-line treatment for OSA. But many patients do not adhere to therapy.

The upper airway(UA) anatomical abnormality is a prominent risk factor in Asian OSA patients, which might be improved by surgical strategies. However, surgery shows variable clinical effectiveness. One important reason for patients responding poorly to single treatment procedure is that multiple abnormal physiological traits contribute to OSA.

High loop gain is one of the key non-anatomical risk factors. It will be useful to individualize therapy in OSA by better understanding the reversibility of increased LG, the interaction of LG and UA anatomical change as well as the condition that trigger reduction of LG.

The project will test the hypothesis of 1) Elevated LG is induced in some patients and is reversible by treatment of OSA; 2) Change of LG is related to the improvement of sleep apnea; 3) An elevated LG is related to residual sleep apnea after upper airway surgery, which might be eliminated by adjunct CPAP therapy after surgery. The results would improve the efficiency of non-CPAP treatment and provide a potential combined treatment option for those patients with both elevated loop gain and anatomy risk factors in the Asian population.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Unstable respiratory control (high loop gain) is an important non-anatomical risk factor for obstructive sleep apnea. Studies showed high loop gain might also be acquired from long-term hypoxemia/hypercapnia due to OSA, and could be decreased by CPAP therapy in some of the individuals. Whether another treatment, i.e. upper airway surgery, could achieve a similar improvement in is not known. We hypothesize that 1) high LG could be reversible with improved hypoxemia and reduced apnea hypopnea index (AHI) by surgical treatment; 2) high loop gain at baseline may be associated with poor treatment outcomes.

PSG was performed pre- and postoperatively to assess the OSA severity in participants who underwent uvulopalatopharyngoplasty and concomitant transpalatal advancement pharyngoplasty. Loop gain were calculated using a published method by fitting a feedback control model to airflow. The loop gain values at baseline and follow-up were compared. The association between loop gain change and improvement of OSA were analyzed.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Beijing Tongren Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Obstructive sleep apnea

Description

Inclusion Criteria:

  • Ages 18-70 years
  • Sleep study (with apnea-hypopnea index>5)
  • Diagnosis of obstructive sleep apnea

Exclusion Criteria:

  • Any known unstable cardiac (apart from treated hypertension), pulmonary, renal, neurologic (including epilepsy), thyroid, neuromuscular, or hepatic disease
  • Pregnant women or nursing mothers
  • Use of any medications that may affect sleep or breathing
  • An uncontrolled psychiatric disorder
  • Use of illicit drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Education and follow up
Participants who refuse or fail to have PAP treatment or Oral appliance or other treatments for sleep apnea. They also refuse or have counter-indication for surgical treatment. The impact of weight loss, sleep position, alcohol avoidance, risk factor modification and medication effects and follow-up are provided for patients' education.
Behavioral: education and follow up
Patients education and follow up:The impact of weight loss, sleep position, alcohol avoidance, risk factor modification and medication effects and follow-up are provided for patients' education.
Upper airway surgery
Participants who undergo uvulopalatopharyngoplasty, concomitant transpalatal advancement pharyngoplasty, nasal surgery or multi-level upper airway surgery.
Procedure: upper airway surgery
Uvulopalatopharyngoplasty, concomitant transpalatal advancement pharyngoplasty, nasal surgery or multi-level upper airway surgery
Continues positive airway pressure
Participants who are treated with continues positive airway pressure during sleep.
Device: Continues positive airway pressure
Participants who are treated with continues positive airway pressure during sleep.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in ventilatory control after intervention
Time Frame: 6 month to 1 year
Loop gain at a disturbance of frequency 1 cycle/minute were calculated using a published method by fitting a feedback control model to airflow
6 month to 1 year
Change from baseline in sleep apnea severity after intervention
Time Frame: 6 month to 1 year
Assess using standard sleep scoring criteria
6 month to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in upper airway anatomy after surgery
Time Frame: 6 month to 1 year
Upper airway computed tomography
6 month to 1 year
Change from baseline in symptoms after intervention
Time Frame: 6 month to 1 year
Assess using questionnaires
6 month to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Collaborators

Beijing Tsinghua Chang Gung Hospital

Investigators

  • Study Director: Demin Han, M.D, Ph.D, Beijing Tongren Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

February 26, 2016

First Submitted That Met QC Criteria

March 1, 2016

First Posted (Estimate)

March 2, 2016

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 26, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRECKY2013-004-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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