NCT05553860

Brief Summary

This is a prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

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

December 5, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2022

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2025

Completed
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

4 years

First QC Date

September 21, 2022

Last Update Submit

March 16, 2026

Conditions

Sleep Apnea, ObstructiveOcclusal Splints

Outcome Measures

Primary Outcomes (1)

  • Apnea-hypopnea index (AHI)

    Measurement to determine whether both mandibular positioning techniques provide similar management of obstructive sleep apnea

    3 months

Secondary Outcomes (1)

  • Overjet

    3 months

Study Arms (2)

Anterior Protrusive

ACTIVE COMPARATOR

use of anterior protrusive positioning technique

Other: Speech positioning technique

Speech Position

EXPERIMENTAL

use of speech positioning technique

Other: Speech positioning technique

Interventions

Speech positioning techniqueOTHER

Speech positioning technique

Anterior ProtrusiveSpeech Position

Eligibility Criteria

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

You may qualify if:

  • Patient diagnosed with obstructive sleep apnea, and
  • Prescription/order for a dental sleep appliance
  • years or older
  • Treatment planned in accordance with AADSM treatment guidelines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Enoch Ng, DDS

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 21, 2022

First Posted

September 23, 2022

Study Start

December 5, 2021

Primary Completion

December 3, 2025

Study Completion

December 3, 2025

Last Updated

March 18, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)