The Impact of Sleep Apnea Treatment on Physiology Traits in Chinese Patients With Obstructive Sleep Apnea
Keywords
Abstract
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.
Dates
| Last Verified: | 06/30/2017 |
| First Submitted: | 02/25/2016 |
| Estimated Enrollment Submitted: | 02/29/2016 |
| First Posted: | 03/01/2016 |
| Last Update Submitted: | 07/25/2017 |
| Last Update Posted: | 07/26/2017 |
| Actual Study Start Date: | 01/31/2016 |
| Estimated Primary Completion Date: | 10/31/2016 |
| Estimated Study Completion Date: | 08/31/2018 |
Condition or disease
Intervention/treatment
Procedure: Upper airway surgery
Device: Continues positive airway pressure
Behavioral: Education and follow up
Phase
Arm Groups
| Arm | 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. |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | All |
| Sampling method | Non-Probability Sample |
| Accepts Healthy Volunteers | Yes |
| 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 |
Outcome
Primary Outcome Measures
1. Change from baseline in ventilatory control after intervention [6 month to 1 year]
2. Change from baseline in sleep apnea severity after intervention [6 month to 1 year]
Secondary Outcome Measures
1. Change from baseline in upper airway anatomy after surgery [6 month to 1 year]
2. Change from baseline in symptoms after intervention [6 month to 1 year]
