NCT05489562

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 5, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 25, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 12, 2023

Status Verified

October 1, 2023

Enrollment Period

9 months

First QC Date

June 10, 2022

Last Update Submit

October 10, 2023

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

  • Number of patients reporting adverse events related to use of intraoral suction to stabilize the tongue as assessed by a survey

    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

    Up to 16 weeks

Secondary Outcomes (2)

  • Effect on sleep duration

    Up to 16 Weeks

  • Effect on sleep quality

    Up to 16 Weeks

Study Arms (1)

Single Arm Mouthguard

OTHER

Subjects wearing mouthguard to access tolerability and comfort of the device

Device: Intraoral Suction

Interventions

Intraoral SuctionDEVICE

stabilization of the tongue using intraoral suctioning and its effects on sleep parameters in patients with obstructive sleep apnea (OSA).

Single Arm Mouthguard

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80
  • Patients newly diagnosed with OSA (a diagnosis of OSA ≤6 months) who may or may not have started using their PAP yet
  • Patients diagnosed \> 6 months but within the past 5 years who are not compliant with positive airway pressure treatment. Non compliance is defined as use of device for an average of \<4 hours/night OR \< 5 nights/week
  • An AHI, REI or RDI or any synonymous term for AHI in the moderate to severe range (15-60)
  • A body mass index (BMI) less than \<=40 (BMI within 1 year of enrollment date)
  • Adequate dentition to support a dental retainer

You may not qualify if:

  • Evidence of central sleep apnea or concomitant sleep disorder other than OSA
  • Currently using MAD or other form of mouth prosthesis to treat OSA
  • Prior surgical treatment for OSA
  • History of anatomic nasal obstruction
  • Use of medications that may affect sleep (hypnotic medications for the treatment of insomnia)
  • Use of pacemaker or implantable cardioverter-defibrillator (ICD)
  • Immunocompromised (i.e., susceptible to infection)
  • Open soars/wounds in patient's mouth
  • Active alcohol abuse or IV drug use

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System

Jamaica Plain, Massachusetts, 02130, United States

RECRUITING

Related Publications (10)

  • 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.

    PMID: 23589584BACKGROUND

  • 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.

    PMID: 18714778BACKGROUND

  • 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.

    PMID: 28966740BACKGROUND

  • 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.

    PMID: 27542595BACKGROUND

  • 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):zsz112. doi: 10.1093/sleep/zsz112.

    PMID: 31106808BACKGROUND

  • 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.

    PMID: 23871259BACKGROUND

  • 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.

    PMID: 31538607BACKGROUND

  • 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.

    PMID: 29351826BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 28846764BACKGROUND

Study Officials

  • Ravi Rasalingam, MD

    VA Boston Healthcare System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ravi Rasalingam, MD

CONTACT

857-203-6840ravi.rasalingam@va.gov

Karen Visnaw, RN

CONTACT

617-459-5620Karen.Visnaw@va.gov

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardiologist

Study Record Dates

First Submitted

June 10, 2022

First Posted

August 5, 2022

Study Start

September 25, 2023

Primary Completion

July 1, 2024

Study Completion

October 1, 2024

Last Updated

October 12, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)