The Effect of Occlusal Splints on Respiratory Variables in Obstructive Sleep Apnea (OSA) Patients

NCT01004692 | Unknown Phase 1

• 2 other identifiers: NL23988.048.08METC 0832
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: The effect of vertical dimension on sleep apnoea and respiratory variables in obstructive sleep apnoea patients. Objective: To what extend should a possible worsening of the OSA condition, caused by an increase of mouth opening be taken into consideration in daily dental practice, when an occlusal stabilization splint (OSS) is placed in the mouth. Study design: Cross over RCT-design Study population: OSA patients referred to ACTA from the Slotervaart Hospital, for treatment with a Mandibular Advancement Device (MAD), at least 18 years old. Intervention: Occlusal stabilization splint (OSS) for the upper jaw and a controlled condition in a cross-over design Main study parameters/endpoints: Apnoea- Hypopnoea Index (AHI) and the Epworth Sleepiness Scale (ESS). The aim of this study is to determine the effect of vertical dimension of OS on sleep and respiratory variables in OSA patients. The hypothesis is that insertion of an OSS and an increase of the vertical dimension will result in a significant increase in the AHI.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• The main study parameter/ endpoint is the Apnoea-Hypopnoea Index (AHI) value

  from all 6 nights

Secondary Outcomes (1)

• The secondary study parameter is the Epworth Sleepiness Scale (ESS)

  from all 6 nights

Interventions

Occlusal splints DEVICE

The splint will be a hard acrylic-resin stabilization appliance to wear in the upper jaw. The OSS does not come in contact with the gums of the patient and does not act as an orthodontic device. The OSS will be used only for the three nights in a row, of the ambulatory-PSG recording with the OSS in situ.

Also known as: occlusal stabilisation splint

Eligibility Criteria

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

You may qualify if:

• \- All patients invited should be at least 18 years old.
• OSA patients, diagnosis based on a baseline polysomnographic recording (at the hospital) with AHI values until 30 (mild+ moderate OSAS).
• Adequate retention in the dentition for an occlusal stabilization splint (OSS).

You may not qualify if:

• \- Medicine usage that influence sleep (eg Benzodiazepines).
• BMI more than 40
• Unhealthy dentition.
• Severe bruxers
• TMD patients

Sponsors & Collaborators

• Academic Centre for Dentistry in Amsterdam: lead

Study Sites (1)

Academical Center for dentistry Amsterdam (ACTA)

Amsterdam, 1066EA, Netherlands

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Occlusal Splints

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)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Frank Lobbezoo, professor

  Academic Centre for Dentistry in Amsterdam

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 29, 2009
• First Posted: October 30, 2009
• Study Start: December 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: June 1, 2010
• Last Updated: October 30, 2009

Record last verified: 2009-10

Locations

NL (1)