NCT00243139

Brief Summary

The purpose of this study was to determine how effective a custom-made standard dental splint (activator) advancing the lower jaw forward is in treatment of obstructive sleep apnea, and further to find factors for identification of those patients likely to benefit from this treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 1999

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 1999

Completed
4.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 20, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2005

Completed
Last Updated

September 15, 2006

Status Verified

September 1, 2006

First QC Date

October 20, 2005

Last Update Submit

September 14, 2006

Conditions

Sleep Apnea SyndromesSleep ApneaObstructive Sleep Apnea

Keywords

Oral appliancesObstructive sleep apneaEpworth Sleepiness ScaleSF-36

Outcome Measures

Primary Outcomes (1)

  • Change in sleep parameters, especially apnea-hypopnea index (AHI).

Secondary Outcomes (2)

  • Change in daytime sleepiness, assessed by Epworth Sleepiness Scale.

  • Change in quality of life, assessed by SF-36.

Interventions

Mandibular advancement device (activator)DEVICE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • AHI \> 5 on polysomnography
  • sufficient set of teeth to hold a splint
  • written informed consent

You may not qualify if:

  • sleep apnea with severe cardiovascular disease
  • other severe somatic or psychiatric disease
  • periodontal disease
  • significant occlusal dysfunction
  • pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nykoebing Falster County Hospital

Nykoebing Falster, Storstrøms County, DK-4800, Denmark

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesSleep Apnea, Obstructive

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Orthotic DevicesOrthopedic EquipmentSurgical EquipmentEquipment and Supplies

Study Officials

  • Niels Petri, MD

    Nykoebing Falster County Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2005

First Posted

October 21, 2005

Study Start

July 1, 1999

Study Completion

February 1, 2004

Last Updated

September 15, 2006

Record last verified: 2006-09

Locations

DK(1)