Use of Intraoral Suction and Its Effects on Obstructive Sleep Apnea

NCT ID: NCT05489562

Last Updated: 2023-10-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-25
• Study Completion Date: 2024-10-31

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.

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.

Conditions

Obstructive Sleep Apnea of Adult

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Single Arm Mouthguard

Subjects wearing mouthguard to access tolerability and comfort of the device

Group Type: OTHER

Intraoral Suction

Intervention Type: DEVICE

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

Interventions

Intraoral Suction

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts Institute of Technology

OTHER

Sponsor Role: collaborator

VA Boston Healthcare System

FED

Sponsor Role: lead

Responsible Party

Ravi Rasalingam, MD

Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ravi Rasalingam, MD

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System

Locations

VA Boston Healthcare System

Jamaica Plain, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ravi Rasalingam, MD

Role: CONTACT

ravi.rasalingam@va.gov

857-203-6840 ext. 34017

Karen Visnaw, RN

Role: CONTACT

Karen.Visnaw@va.gov

617-459-5620

Facility Contacts

Karen Visnaw, RN

Role: primary

Karen.Visnaw@va.gov

617-459-5620

Douglas Clinton, RPh

Role: backup

douglas.Clinto@va.gov

617-390-4522

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Other Identifiers

1686683

Identifier Type: -

Identifier Source: org_study_id