Dual Obstructive Sleep Apnea Therapy

NCT03435731 | Unknown

• 2 other identifiers: H18-00175FCRC1801
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

Continuous positive airway pressure (CPAP) is considered the gold standard therapy for obstructive sleep apnea (OSA). However, CPAP users sometimes experience pressure-related discomfort. It is thought that lower CPAP pressure may increase comfort and lead to greater treatment adherence. Mandibular advancement splint (MAS) therapy has been shown to be the preferred OSA treatment option among patients. However, MAS therapy is only partially effective in some OSA patients, especially in severe cases. It is thought that a combination of MAS and PAP therapy may benefit patients in which MAS alone is only partially effective. Using MAS and PAP at the same time is called "Dual Therapy". Dual Therapy may allow a lower CPAP pressure to be applied, which may increase patient comfort and therefore increase treatment adherence and overall effectiveness. This study will evaluate the effectiveness of 1 month of Dual Therapy in 30 OSA patients.

Conditions

Obstructive Sleep Apnea

Keywords

OSA; Continous Positive Airway Pressure (CPAP); Mandibular Advancement Split (MAS); Mandibular Advancement Oral Appliance; Dual Therapy

Outcome Measures

Primary Outcomes (4)

• Change in CPAP Pressure

  Optimal CPAP Pressure determined by the Respiratory Therapist (cmH2O)

  Baseline (from previous treatment with CPAP) and 1 month after commencing Dual Therapy treatment.

• Comfort

  A subjective assessment of the Dual Therapy treatment, reported via a questionnaire.

  Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.

• Treatment Adherence (hrs/night)

  Adherence measured in hours per night.

  The duration of Dual Therapy treatment (1 month).

• Treatment Adherence (% nights)

  Adherence measured in percentage of nights of use.

  The duration of Dual Therapy treatment (1 month).

Secondary Outcomes (5)

• Daytime Sleepiness

  Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.

• Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)

  Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.

• Efficacy - Oxygen Desaturation Index

  Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.

• Efficacy - Time below 90% Saturation

  Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.

• Efficacy - Minimum Saturation

  Baseline (from previous treatment) and 1 month after commencing Dual Therapy treatment.

Study Arms (1)

Treatment Group

EXPERIMENTAL

This group will undergo 1 month Dual Therapy.

Combination Product: Dual Therapy

Interventions

Dual Therapy COMBINATION_PRODUCT

Concomitant use of Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Splint (MAS) therapeutic devices.

Treatment Group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19-80 years old who are able to freely provide informed consent;
• Prior participation in the CHOICE study;
• Have been optimally titrated to PAP and MAS therapy;
• Have both PAP and MAS appliances at home and ready for use;
• Body mass index (BMI) of 35 or less;
• ≥ 8 teeth per arch to support treatment with MAS;
• Have an objective of diagnosis of OSA based on the following criteria:
• \- an Apnea-Hypopnea Index (AHI) within the range 10 ≤ AHI ≤ 70 documented with polysomnography in the last 2 years; \*\*\*OR\*\*\*
• \- a Respiratory Disturbance Index (RDI) within the range 20 ≤ RDI ≤ 70 documented with level III portable sleep test; \*\*\*OR\*\*\*
• \- an Oxygen Desaturation Index (ODI) ≥ 10;
• Sleep investigations confirming the object diagnosis of OSA have been performed within the past 4 years

You may not qualify if:

• Use of a full face mask as the PAP interface;
• Extensive periodontal disease with significant tooth mobility;
• Inability to protrude jaw;
• Insufficient vertical opening to accommodate treatment with MAS;
• Uncontrolled congestive heart failure (defined as a prior clinical diagnosis, an ejection cut-off of 40% or clinical sign in the opinion of a primary care physician or cardiologist) that makes it unsafe in the opinion of the investigators for the subject to participate in the trial;
• Coronary artery disease unless stable for at least 6 months and considered by the investigators to have a stable disease;
• Any history of angina, myocardial infarction or stroke;
• Any history of major depressive disorder along with current moderate-severe disease;
• Active cancer management (unless in remission for more than 1 year);
• Known renal failure (with need for dialysis);
• History of a near miss or prior automobile accident due to sleepiness within the past 12 months;
• At nighttime, 30% of the night is at ≤ 90% oxygen saturation levels.

Sponsors & Collaborators

• University of British Columbia: lead
• Université de Montréal: collaborator

Study Sites (2)

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

Location

Université de Montréal

Montreal, Quebec, H3T 1J4, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Dual Anti-Platelet Therapy

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy, Combination; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2018
• First Posted: February 19, 2018
• Study Start: March 8, 2018
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 2, 2018

Record last verified: 2018-04

Locations

CA (2)