Clinical trial NCT02696629: The Impact of Sleep Apnea Treatment on Physiology Traits in Chinese Patients With Obstructive Sleep Apnea
Official title: The Impact of Sleep Apnea Treatment on Physiology Traits in Chinese Patients With Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obstructive Sleep Apnea
Keywords: Ventilatory control
Obstructive sleep apnea
Loop gain
Upper airway
Surgery
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Tsinghua Chang Gung Hospital
First posted: 2016-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obstructive sleep apnea

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.

Eligibility 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

Primary outcomes:
measure: Change from baseline in ventilatory control after intervention
timeFrame: 6 month to 1 year
measure: Change from baseline in sleep apnea severity after intervention
timeFrame: 6 month to 1 year
Secondary outcomes:
measure: Change from baseline in upper airway anatomy after surgery
timeFrame: 6 month to 1 year
measure: Change from baseline in symptoms after intervention
timeFrame: 6 month to 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital
state: Beijing
Study officials:
affiliation: Beijing Tongren Hospital
name: Demin Han, M.D, Ph.D
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.