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

NCT02696629 | Unknown

• 1 other identifier: TRECKY2013-004-1
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

Ventilatory control; Obstructive sleep apnea; Loop gain; Upper airway; Surgery

Outcome Measures

Primary Outcomes (2)

• Change from baseline in ventilatory control after intervention

  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

  Assess using standard sleep scoring criteria

  6 month to 1 year

Secondary Outcomes (2)

• Change from baseline in upper airway anatomy after surgery

  6 month to 1 year

• Change from baseline in symptoms after intervention

  6 month to 1 year

Study Arms (3)

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

Upper airway surgery

Participants who undergo uvulopalatopharyngoplasty, concomitant transpalatal advancement pharyngoplasty, nasal surgery or multi-level upper airway surgery.

Procedure: upper airway surgery

Continues positive airway pressure

Participants who are treated with continues positive airway pressure during sleep.

Device: Continues positive airway pressure

Interventions

upper airway surgery PROCEDURE

Uvulopalatopharyngoplasty, concomitant transpalatal advancement pharyngoplasty, nasal surgery or multi-level upper airway surgery

Upper airway surgery

Continues positive airway pressure DEVICE

Participants who are treated with continues positive airway pressure during sleep.

Continues positive airway pressure

education and follow up BEHAVIORAL

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.

Education and follow up

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obstructive sleep apnea

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead
• Beijing Tsinghua Chang Gung Hospital: collaborator

Study Sites (1)

Beijing Tongren Hospital

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (6)

• Wellman A, Jordan AS, Malhotra A, Fogel RB, Katz ES, Schory K, Edwards JK, White DP. Ventilatory control and airway anatomy in obstructive sleep apnea. Am J Respir Crit Care Med. 2004 Dec 1;170(11):1225-32. doi: 10.1164/rccm.200404-510OC. Epub 2004 Aug 18.

  PMID: 15317668 BACKGROUND

• Owens RL, Edwards BA, Eckert DJ, Jordan AS, Sands SA, Malhotra A, White DP, Loring SH, Butler JP, Wellman A. An Integrative Model of Physiological Traits Can be Used to Predict Obstructive Sleep Apnea and Response to Non Positive Airway Pressure Therapy. Sleep. 2015 Jun 1;38(6):961-70. doi: 10.5665/sleep.4750.

  PMID: 25515107 BACKGROUND

• Terrill PI, Edwards BA, Nemati S, Butler JP, Owens RL, Eckert DJ, White DP, Malhotra A, Wellman A, Sands SA. Quantifying the ventilatory control contribution to sleep apnoea using polysomnography. Eur Respir J. 2015 Feb;45(2):408-18. doi: 10.1183/09031936.00062914. Epub 2014 Oct 16.

  PMID: 25323235 BACKGROUND

• Loewen A, Ostrowski M, Laprairie J, Atkar R, Gnitecki J, Hanly P, Younes M. Determinants of ventilatory instability in obstructive sleep apnea: inherent or acquired? Sleep. 2009 Oct;32(10):1355-65. doi: 10.1093/sleep/32.10.1355.

  PMID: 19848364 BACKGROUND

• Li Y, Ye J, Han D, Zhao D, Cao X, Orr J, Jen R, Deacon-Diaz N, Sands SA, Owens R, Malhotra A. The Effect of Upper Airway Surgery on Loop Gain in Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Jun 15;15(6):907-913. doi: 10.5664/jcsm.7848.

  PMID: 31138381 DERIVED

• Li Y, Ye J, Han D, Cao X, Ding X, Zhang Y, Xu W, Orr J, Jen R, Sands S, Malhotra A, Owens R. Physiology-Based Modeling May Predict Surgical Treatment Outcome for Obstructive Sleep Apnea. J Clin Sleep Med. 2017 Sep 15;13(9):1029-1037. doi: 10.5664/jcsm.6716.

  PMID: 28818154 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Demin Han, M.D, Ph.D

  Beijing Tongren Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: February 26, 2016
• First Posted: March 2, 2016
• Study Start: February 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: September 1, 2018
• Last Updated: July 27, 2017

Record last verified: 2017-07

Locations

CN (1)