The Use of Oral Appliances as an Adjunct to Continuous Positive Airway Pressure (CPAP) in the Treatment of Obstructive Sleep Apnoea

NCT00358605 | Completed

• 1 other identifier: H05-70075
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This study will look at whether patients with OSAHS already successfully treated with nasal CPAP could successfully use an oral appliance as a short-term treatment alternative and whether patients who could use an oral appliance as an alternative would actually avail of its use, and to assess their preference in terms of treatment modality. The combination of therapies if tolerated, will allow greater flexibility of treatment and opportunity for ongoing compliance in circumstances where CPAP cannot be used.

Conditions

Obstructive Sleep Apnoea

Keywords

OSAHS; Oral Appliance; Hypopnoea Syndrome

Outcome Measures

Primary Outcomes (1)

• This study will compare apnea-hypopnea index (AHI) before and during oral appliance use.

Secondary Outcomes (4)

• This study will compare Epworth Sleepiness Score, arousal index and sleep efficiency index between before and during oral appliance therapy.

• It will compare the change in Sleep Apnea Quality of Life Index while on CPAP from baseline to while on Oral appliance.

• Overall treatment compliance

• Overall sleepiness score (subjective)

Interventions

The Klearway™ oral appliance DEVICE

See Detailed Description.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• stable on C-PAP for at least 3 months, and
• Previous diagnostic polysomnography ithin 2 years, and
• Pre-treatment AHI 10-30 ( mild-moderate sleep apnea), and
• Compliance \> 4hrs per night, and
• are willing and able to give informed consent

You may not qualify if:

• AHI \>30, or
• Oxygen Saturation \< 85% for \> 10% of study time during previous diagnostic PSG;
• Or less than 8 teeth per jaw;
• Or not enough teeth in good periodontal health to allow retention of the appliance;
• Clinical evidence of severe tempero-mandibular joint dysfunction;
• Operates heavy machinery or motor vehicle as part of job;
• previous Motor Vehicle Crash assoc. with sleepiness;
• or major cardiovascular morbidity;
• or medically complicated or medically unstable.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Vancouver Acute Sleep Disorder Program, UBC Hospital

Vancouver, British Columbia, Canada

Location

Related Publications (1)

• Almeida FR, Mulgrew A, Ayas N, Tsuda H, Lowe AA, Fox N, Harrison S, Fleetham JA. Mandibular advancement splint as short-term alternative treatment in patients with obstructive sleep apnea already effectively treated with continuous positive airway pressure. J Clin Sleep Med. 2013 Apr 15;9(4):319-24. doi: 10.5664/jcsm.2576.

  PMID: 23585745 RESULT

Related Links

• Related Info

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• John Fleetham, MD, FCRC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2006
• First Posted: August 1, 2006
• Study Start: August 1, 2005
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 20, 2016

Record last verified: 2016-05

Locations

CA (1)