Consequences of Obstructive Sleep Apnea on Respiratory Function Following Weight-loss Surgery
NCT ID: NCT01697878
Last Updated: 2016-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
45 participants
INTERVENTIONAL
2012-03-31
2016-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Nasal Continuous Positive Airway Pressure and Airway Patency in Obese Patient
NCT03024723
Weight Gain After CPAP Treatment in Patients With Obstructive Sleep Apnea
NCT03567317
Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea
NCT05253963
Impact of Automatic Positive Airway Pressure on Treatment Compliance in OSA Patients Awaiting Bariatric Surgery
NCT02209220
Effect of Weight Loss and CPAP on OSA and Metabolic Profile Stratified by Craniofacial Phenotype
NCT03287973
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Randomization Group 1
CPAP first followed by standard of care
CPAP followed by atmospheric pressure
In the PACU, Patients receive 2 hours of continuous-positive-airway-pressure (CPAP) oxygen at 30% FiO2 treatment followed by 2 hours of oxygen treatment (6 L O2/min) that is part of standard of care at Massachusetts General Hospital
Randomization group 2
Standard of care followed by CPAP
Atmospheric pressure followed by CPAP
In the PACU, patients receive 2 hours of Oxygen treatment (6L/min) that is part of standard-of-care at Massachusetts General Hospital, followed by 2 hours of Continuous Positive Airway Pressure (CPAP) treatment at 30% FiO2.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CPAP followed by atmospheric pressure
In the PACU, Patients receive 2 hours of continuous-positive-airway-pressure (CPAP) oxygen at 30% FiO2 treatment followed by 2 hours of oxygen treatment (6 L O2/min) that is part of standard of care at Massachusetts General Hospital
Atmospheric pressure followed by CPAP
In the PACU, patients receive 2 hours of Oxygen treatment (6L/min) that is part of standard-of-care at Massachusetts General Hospital, followed by 2 hours of Continuous Positive Airway Pressure (CPAP) treatment at 30% FiO2.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Male and female subjects
* age ≥ 18 years
Exclusion Criteria
* age \< 18 years
* missing or insufficient PSG data to make diagnosis OSA
* impaired decision making capacity
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ResMed
INDUSTRY
Massachusetts General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Matthias Eikermann
Assistant Pofessor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Matthias Eikermann, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Malbois M, Giusti V, Suter M, Pellaton C, Vodoz JF, Heinzer R. Oximetry alone versus portable polygraphy for sleep apnea screening before bariatric surgery. Obes Surg. 2010 Mar;20(3):326-31. doi: 10.1007/s11695-009-0055-9. Epub 2010 Jan 6.
Longitudinal Assessment of Bariatric Surgery (LABS) Consortium; Flum DR, Belle SH, King WC, Wahed AS, Berk P, Chapman W, Pories W, Courcoulas A, McCloskey C, Mitchell J, Patterson E, Pomp A, Staten MA, Yanovski SZ, Thirlby R, Wolfe B. Perioperative safety in the longitudinal assessment of bariatric surgery. N Engl J Med. 2009 Jul 30;361(5):445-54. doi: 10.1056/NEJMoa0901836.
Peppard PE, Young T, Palta M, Skatrud J. Prospective study of the association between sleep-disordered breathing and hypertension. N Engl J Med. 2000 May 11;342(19):1378-84. doi: 10.1056/NEJM200005113421901.
Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. doi: 10.1001/jama.283.14.1829.
Faccenda JF, Mackay TW, Boon NA, Douglas NJ. Randomized placebo-controlled trial of continuous positive airway pressure on blood pressure in the sleep apnea-hypopnea syndrome. Am J Respir Crit Care Med. 2001 Feb;163(2):344-8. doi: 10.1164/ajrccm.163.2.2005037.
Yaggi HK, Concato J, Kernan WN, Lichtman JH, Brass LM, Mohsenin V. Obstructive sleep apnea as a risk factor for stroke and death. N Engl J Med. 2005 Nov 10;353(19):2034-41. doi: 10.1056/NEJMoa043104.
Meoli AL, Rosen CL, Kristo D, Kohrman M, Gooneratne N, Aguillard RN, Fayle R, Troell R, Kramer R, Casey KR, Coleman J Jr; Clinical Practice Review Committee; American Academy of Sleep Medicine. Upper airway management of the adult patient with obstructive sleep apnea in the perioperative period--avoiding complications. Sleep. 2003 Dec 15;26(8):1060-5. doi: 10.1093/sleep/26.8.1060.
Loadsman JA, Hillman DR. Anaesthesia and sleep apnoea. Br J Anaesth. 2001 Feb;86(2):254-66. doi: 10.1093/bja/86.2.254.
Hillman DR, Loadsman JA, Platt PR, Eastwood PR. Obstructive sleep apnoea and anaesthesia. Sleep Med Rev. 2004 Dec;8(6):459-71. doi: 10.1016/j.smrv.2004.07.002.
Mezzanotte WS, Tangel DJ, White DP. Influence of sleep onset on upper-airway muscle activity in apnea patients versus normal controls. Am J Respir Crit Care Med. 1996 Jun;153(6 Pt 1):1880-7. doi: 10.1164/ajrccm.153.6.8665050.
Hajiha M, DuBord MA, Liu H, Horner RL. Opioid receptor mechanisms at the hypoglossal motor pool and effects on tongue muscle activity in vivo. J Physiol. 2009 Jun 1;587(Pt 11):2677-92. doi: 10.1113/jphysiol.2009.171678. Epub 2009 Apr 29.
White DP. Opioid-induced suppression of genioglossal muscle activity: is it clinically important? J Physiol. 2009 Jul 15;587(Pt 14):3421-2. doi: 10.1113/jphysiol.2009.176388. No abstract available.
Gross JB, Bachenberg KL, Benumof JL, Caplan RA, Connis RT, Cote CJ, Nickinovich DG, Prachand V, Ward DS, Weaver EM, Ydens L, Yu S; American Society of Anesthesiologists Task Force on Perioperative Management. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: a report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2006 May;104(5):1081-93; quiz 1117-8. doi: 10.1097/00000542-200605000-00026. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ResMed
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2011P001333
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.