NCT02148510

Brief Summary

The hypothesis of the study is that a bibloc-apnea splint has a comparable efficacy on respiratory measures as a monobloc-apnea splint and that the cost of treatment is the same. The goal is primarily to compare the Apnea-Hypopnea Index (AHI) after 6 weeks of treatment and the cost of treatment during one year. This randomized controlled parallel group multicenter study includes 316 subjects referred for the treatment of moderate to severe Obstructive Sleep Apnea (OSA). The subjects visit the clinic at 5 scheduled occasions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
313

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

May 1, 2014

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2017

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

2 years

First QC Date

May 16, 2014

Last Update Submit

November 6, 2017

Conditions

Obstructive Sleep Apnea

Keywords

humansleep apneaadultsoral applianceefficacysafetypolygraphybruxismcost

Outcome Measures

Primary Outcomes (1)

  • Apnoea-Hypopnea-Index (AHI)

    AHI defined by American Academy of Sleep Medicine (AASM)

    9 weeks after start of study

Secondary Outcomes (5)

  • Oxygen Desaturation Index (ODI)

    9 weeks

  • Sleepiness

    9 weeks and 1 year

  • Quality of life

    9 weeks and 1 year

  • Sleep bruxism

    9 weeks

  • Adverse events

    1 year

Other Outcomes (1)

  • Cost of care

    1 year

Study Arms (2)

Monobloc

EXPERIMENTAL

Treatment with an appliance that holds the lower jaw in a fixed protruded position

Device: Monobloc

Bibloc

ACTIVE COMPARATOR

Bibloc device where a maxillary splint is connected to a mandibular splint by a connector allowing a slight opening of the jaw without compromizing the protrusion (Narval)

Device: Bibloc

Interventions

MonoblocDEVICE

Construction fitted to upper and lower jaw

Also known as: Mandibular protruding device
Monobloc
BiblocDEVICE

Biblock construction

Also known as: Narval
Bibloc

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The diagnosis of obstructive sleep apnea with AHI \> 15
  • Odontological status that allows retention of oral devices and with at least one molar in each quadrant
  • Maximal protrusion \>6 mm
  • Subject giving his/her informed concent
  • Understands and can communicate in Swedish
  • Subject understands the instruction on how to put on the polygraphy equipment at home
  • Valid AHI data at baseline respiratory analysis

You may not qualify if:

  • age\< 18 år
  • BMI \>35
  • Jaw complaints requiring treatment the past year
  • Pain or locking of the jaw at the enrollment visit
  • At the discretion of the investigator judged not being able to attach to the study directives
  • Hypersensitive to the material of the devices
  • Ongoing Continuous Positive Airway Pressure (CPAP) treatment or oral device treatment or such treatment terminated within a month from enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Västmanland County Hospitals

Västerås, Västmanland County, 72189, Sweden

Location

Postgraduate Dental Education Center

Örebro, 70111, Sweden

Location

Related Publications (1)

  • Isacsson G, Nohlert E, Fransson AMC, Bornefalk-Hermansson A, Wiman Eriksson E, Ortlieb E, Trepp L, Avdelius A, Sturebrand M, Fodor C, List T, Schumann M, Tegelberg A. Use of bibloc and monobloc oral appliances in obstructive sleep apnoea: a multicentre, randomized, blinded, parallel-group equivalence trial. Eur J Orthod. 2019 Jan 23;41(1):80-88. doi: 10.1093/ejo/cjy030.

    PMID: 29771314DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructiveSleep Apnea SyndromesBruxism

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesTooth DiseasesStomatognathic DiseasesHabitsBehavior

Study Officials

  • Goran Isacsson, assoc prof

    Västmanlands County hospital Västerås, Sweden

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2014

First Posted

May 28, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 15, 2017

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations

SE(2)