Obstructive Sleep ApneaNCT02696629
The Impact of Sleep Apnea Treatment on Physiology Traits in Chinese Patients With Obstructive Sleep Apnea
An observational study of Obstructive Sleep Apnea, run by Beijing Tongren Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- upper airway surgery, Continues positive airway pressure and education and follow up
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Feb 2016to Sep 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obstructive sleep apnea
Who may be able to join
- Ages 18-70 years
- Sleep study (with apnea-hypopnea index>5)
- Diagnosis of obstructive sleep apnea
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- upper airway surgery, Continues positive airway pressure, education and follow up
- Keywords
- Ventilatory control, Obstructive sleep apnea, Loop gain, Upper airway, Surgery
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
upper airway surgeryProcedure or surgery
Uvulopalatopharyngoplasty, concomitant transpalatal advancement pharyngoplasty, nasal surgery or multi-level upper airway surgery
Continues positive airway pressureDevice
Participants who are treated with continues positive airway pressure during sleep.
education and follow upBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: education and follow up | |
| Upper airway surgery | Participants who undergo uvulopalatopharyngoplasty, concomitant transpalatal advancement pharyngoplasty, nasal surgery or multi-level upper airway surgery. Receives: Procedure: upper airway surgery | |
| Continues positive airway pressure | Participants who are treated with continues positive airway pressure during sleep. Receives: Device: Continues positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 month to 1 year
Change from baseline in sleep apnea severity after intervention
Assess using standard sleep scoring criteria
Measured: 6 month to 1 year
Secondary outcomes (2)
Change from baseline in upper airway anatomy after surgery
Upper airway computed tomography
Measured: 6 month to 1 year
Change from baseline in symptoms after intervention
Assess using questionnaires
Measured: 6 month to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startFeb 2016
- Primary completionNov 2016
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Beijing Tongren HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tongren Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Tsinghua Chang Gung Hospital
- Responsible party
- Principal investigator, YANRU LI, Beijing Tongren Hospital
- Investigators
- Demin Han, M.D, Ph.D, Study director, Beijing Tongren Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696629
- Sponsor's protocol ID
- TRECKY2013-004-1
- Status last verified
- Jul 2017
- First submitted
- 26 Feb 2016
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15317668Owens 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.
PubMed 25515107Terrill 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.
PubMed 25323235Loewen 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.
PubMed 19848364Li 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.
PubMed 31138381Li 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.
PubMed 28818154
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sleep Apnea Treatment on Physiology Traits in Chinese Patients With Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02696629
- Acronym / sponsor ID
- TRECKY2013-004-1
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Ventilatory control, Obstructive sleep apnea, Loop gain, Upper airway, Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Tongren HospitalUniversity, hospital or other
- Collaborators
- Beijing Tsinghua Chang Gung Hospital
- Study start
- Feb 2016
- Primary completion
- Nov 2016 (actual)
- Study completion
- Sep 2018 (estimated)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education and follow up | – | Behavioral: education and follow upParticipants 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. |
| Upper airway surgery | – | Procedure: upper airway surgeryParticipants who undergo uvulopalatopharyngoplasty, concomitant transpalatal advancement pharyngoplasty, nasal surgery or multi-level upper airway surgery. |
| Continues positive airway pressure | – | Device: Continues positive airway pressureParticipants who are treated with continues positive airway pressure during sleep. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obstructive sleep apnea
Key inclusion criteria (3 listed)
- Ages 18-70 years
- Sleep study (with apnea-hypopnea index>5)
- Diagnosis of obstructive sleep apnea
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| upper airway surgeryUvulopalatopharyngoplasty, concomitant transpalatal advancement pharyngoplasty, nasal surgery or multi-level upper airway surgery | Procedure or surgery | Upper airway surgery |
| Continues positive airway pressureParticipants who are treated with continues positive airway pressure during sleep. | Device | Continues positive airway pressure |
| education and follow upPatients 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. | Behavioural | Education and follow up |
Primary outcome
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
Change from baseline in sleep apnea severity after intervention
Time frame: 6 month to 1 year
Assess using standard sleep scoring criteria
2 secondary outcomes
Change from baseline in upper airway anatomy after surgery
Time frame: 6 month to 1 year
Change from baseline in symptoms after intervention
Time frame: 6 month to 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2017.
- Background: PubMed 15317668Wellman 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.
- Background: PubMed 25515107Owens 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.
- Background: PubMed 25323235Terrill 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.
- Background: PubMed 19848364Loewen 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.
- Derived from this study: PubMed 31138381Li 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.
- Derived from this study: PubMed 28818154Li 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Demin Han, M.D, Ph.D study director
Beijing Tongren Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Beijing Tongren Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in ventilatory control after intervention (time frame: 6 month to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02696629, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2017.