Use of Intraoral Suction and Its Effects on Obstructive Sleep Apnea
Study Details
Study Description
Brief Summary
To learn whether stabilization of the tongue using intraoral suction is tolerable and what effects this approach has on sleep parameters in obstructive sleep apnea.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Patients who are newly diagnosed with moderate OSA or diagnosed with OSA in the past 5 years and who are not compliant with continuous positive airway pressure treatment will be identified from the Boston VA Healthcare Sleep Laboratory database and invited to participate in the study. Those patients interested in participating will be consented and then evaluated for adequate nasal patency and oral dentition to assess their eligibility for the study. This is a pilot study primarily assessing tolerability of using intraoral suction to stabilise the tongue at night as well as its effects on sleep parameters. Target enrollment is 40 patients. Those enrolled will have a digital intra-oral scan performed and a custom-fit mouthguard that can transmit low level intermittent suction fabricated. The participant will wear this mouthguard for up to five consecutive nights. They will complete a survey designed to assess tolerability following five nights of wearing the mouthguard. The participant will then have a two night in-hospital polysomnography performed one night with the mouthguard transmitting suction and a second night with no suction. The outcomes will be measured using the tolerability survey scores and the duration and quality of sleep as measured by polysomnography.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Single Arm Mouthguard Subjects wearing mouthguard to access tolerability and comfort of the device |
Device: Intraoral Suction
stabilization of the tongue using intraoral suctioning and its effects on sleep parameters in patients with obstructive sleep apnea (OSA).
|
Outcome Measures
Primary Outcome Measures
- Number of patients reporting adverse events related to use of intraoral suction to stabilize the tongue as assessed by a survey [Up to 16 weeks]
Tolerability and comfort will be assessed by a survey completed by each study subject. Number of patients reporting moderate or more severe pain related to use of intraoral suction to stabilize the tongue as assessed by a self-reported survey using a 5-point pain scale. The survey will be completed by each study subject after having worn the mouthguard for up to 5 consecutive nights in a row. Moderate to severe pain is classified as a score of 3 or higher.after their having worn the mouthguard for up to 5 consecutive nights in a row
Secondary Outcome Measures
- Effect on sleep duration [Up to 16 Weeks]
Change in sleep duration (minutes) with and without intraoral suction as measured by polysomnography
- Effect on sleep quality [Up to 16 Weeks]
Change in percentage time in rapid eye movement (REM) with and without intraoral suction as measured by polysomnography
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age 18-75
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Patients newly diagnosed with OSA or patients diagnosed within the past 5 years who are not compliant with continuous positive airway pressure treatment
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An Apnea Hypopnea Index in the moderate range (15-30)
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A body mass index (BMI) less than 40
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Currently using Continuous positive airway pressure (CPAP) with a documented non-compliance of <4 hours/night for 5 nights per week but have at least used the mouthguard within the month prior to enrollment.
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Adequate dentition to support a dental retainer
Exclusion Criteria:
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Evidence of central sleep apnea or concomitant sleep disorder other than OSA
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Currently using Mandibular Advancement Devices (MAD) or other form of mouth prosthesis to treat OSA
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Prior surgical treatment for OSA
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History of Chronic Insomnia
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History of anatomic nasal obstruction
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Use of medications that may affect sleep
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Use of pacemaker or implantable cardioverter-defibrillator (ICD).
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Immunocompromised (i.e., susceptible to infection).
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Infected with HIV or Hepatitis B.
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Open soars/wounds in patient's mouth.
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Active history of alcohol abuse or IV drug use
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- VA Boston Healthcare System
- Massachusetts Institute of Technology
Investigators
- Principal Investigator: Ravi Rasalingam, MD, VA Boston Healthcare System
Study Documents (Full-Text)
None provided.More Information
Publications
- Caldwell JA, Knapik JJ, Shing TL, Kardouni JR, Lieberman HR. The association of insomnia and sleep apnea with deployment and combat exposure in the entire population of US army soldiers from 1997 to 2011: a retrospective cohort investigation. Sleep. 2019 Aug 1;42(8). pii: zsz112. doi: 10.1093/sleep/zsz112.
- Colrain IM, Black J, Siegel LC, Bogan RK, Becker PM, Farid-Moayer M, Goldberg R, Lankford DA, Goldberg AN, Malhotra A. A multicenter evaluation of oral pressure therapy for the treatment of obstructive sleep apnea. Sleep Med. 2013 Sep;14(9):830-7. doi: 10.1016/j.sleep.2013.05.009. Epub 2013 Jul 17.
- Lee CHK, Leow LC, Song PR, Li H, Ong TH. Acceptance and Adherence to Continuous Positive Airway Pressure Therapy in patients with Obstructive Sleep Apnea (OSA) in a Southeast Asian privately funded healthcare system. Sleep Sci. 2017 Apr-Jun;10(2):57-63. doi: 10.5935/1984-0063.20170010.
- Leng Y, McEvoy CT, Allen IE, Yaffe K. Association of Sleep-Disordered Breathing With Cognitive Function and Risk of Cognitive Impairment: A Systematic Review and Meta-analysis. JAMA Neurol. 2017 Oct 1;74(10):1237-1245. doi: 10.1001/jamaneurol.2017.2180. Review. Erratum in: JAMA Neurol. 2018 Jan 1;75(1):133.
- Opportunities Missed to Contain Spending on Sleep Apnea Devices and Improve Veterans' Outcomes. Department of Veterans Affairs - Office of Inspector General; January 14, 2020 2020
- Peppard PE, Young T, Barnet JH, Palta M, Hagen EW, Hla KM. Increased prevalence of sleep-disordered breathing in adults. Am J Epidemiol. 2013 May 1;177(9):1006-14. doi: 10.1093/aje/kws342. Epub 2013 Apr 14.
- Rotenberg BW, Murariu D, Pang KP. Trends in CPAP adherence over twenty years of data collection: a flattened curve. J Otolaryngol Head Neck Surg. 2016 Aug 19;45(1):43. doi: 10.1186/s40463-016-0156-0. Review.
- Sarmiento KF, Folmer RL, Stepnowsky CJ, Whooley MA, Boudreau EA, Kuna ST, Atwood CW, Smith CJ, Yarbrough WC. National Expansion of Sleep Telemedicine for Veterans: The TeleSleep Program. J Clin Sleep Med. 2019 Sep 15;15(9):1355-1364. doi: 10.5664/jcsm.7934. Review.
- Truong KK, De Jardin R, Massoudi N, Hashemzadeh M, Jafari B. Nonadherence to CPAP Associated With Increased 30-Day Hospital Readmissions. J Clin Sleep Med. 2018 Feb 15;14(2):183-189. doi: 10.5664/jcsm.6928.
- Young T, Finn L, Peppard PE, Szklo-Coxe M, Austin D, Nieto FJ, Stubbs R, Hla KM. Sleep disordered breathing and mortality: eighteen-year follow-up of the Wisconsin sleep cohort. Sleep. 2008 Aug;31(8):1071-8.
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