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

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ClinicalTrials.gov Identifier: NCT02696629
Recruitment Status : Unknown
Verified July 2017 by YANRU LI, Beijing Tongren Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 2, 2016
Last Update Posted : July 27, 2017
Sponsor:
Collaborator:
Beijing Tsinghua Chang Gung Hospital
Information provided by (Responsible Party):
YANRU LI, Beijing Tongren Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
Obstructive Sleep Apnea Procedure: upper airway surgery Device: Continues positive airway pressure Behavioral: education and follow up

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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: The Impact of Sleep Apnea Treatment on Physiology Traits in Chinese Patients With Obstructive Sleep Apnea
Study Start Date : February 2016
Actual Primary Completion Date : November 2016
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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.




Primary Outcome Measures :
  1. 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

  2. Change from baseline in sleep apnea severity after intervention [ Time Frame: 6 month to 1 year ]
    Assess using standard sleep scoring criteria


Secondary Outcome Measures :
  1. Change from baseline in upper airway anatomy after surgery [ Time Frame: 6 month to 1 year ]
    Upper airway computed tomography

  2. Change from baseline in symptoms after intervention [ Time Frame: 6 month to 1 year ]
    Assess using questionnaires



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Obstructive sleep apnea
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696629


Locations
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China, Beijing
Beijing Tongren Hospital
Beijing, Beijing, China, 100730
Sponsors and Collaborators
Beijing Tongren Hospital
Beijing Tsinghua Chang Gung Hospital
Investigators
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Study Director: Demin Han, M.D, Ph.D Beijing Tongren Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: YANRU LI, M.D., Beijing Tongren Hospital
ClinicalTrials.gov Identifier: NCT02696629     History of Changes
Other Study ID Numbers: TRECKY2013-004-1
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by YANRU LI, Beijing Tongren Hospital:
Ventilatory control
Obstructive sleep apnea
Loop gain
Upper airway
Surgery

Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases