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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02696629
Enrollment
60
Registered
2016-03-02
Start date
2016-02-29
Completion date
2018-09-30
Last updated
2017-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

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

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.

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.

Interventions

PROCEDUREupper airway surgery

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

DEVICEContinues positive airway pressure

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

BEHAVIORALeducation 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.

Sponsors

Beijing Tsinghua Chang Gung Hospital
CollaboratorOTHER
Beijing Tongren Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change from baseline in ventilatory control after intervention6 month to 1 yearLoop gain at a disturbance of frequency 1 cycle/minute were calculated using a published method by fitting a feedback control model to airflow
Change from baseline in sleep apnea severity after intervention6 month to 1 yearAssess using standard sleep scoring criteria

Secondary

MeasureTime frameDescription
Change from baseline in upper airway anatomy after surgery6 month to 1 yearUpper airway computed tomography
Change from baseline in symptoms after intervention6 month to 1 yearAssess using questionnaires

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026