Treatment Study of Soft Palatal Implants in Obstructive Sleep Apnea
A Randomized, Controlled Treatment Trial of Soft Palatal Implants and Positive Airway Pressure in Mild to Moderate Obstructive Sleep Apnea and Snoring
2 other identifiers
interventional
64
1 country
1
Brief Summary
The purpose of the study is to compare the effectiveness of soft palatal implants with placebo and continuous positive airway pressure treatment in obstructive sleep apnea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2005
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 7, 2005
CompletedFirst Posted
Study publicly available on registry
December 9, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedMay 20, 2011
May 1, 2011
1.8 years
December 7, 2005
May 18, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
apnea-hypopnea index
90 days
Secondary Outcomes (4)
sleepiness
90 days
quality of life
90 days
ambulatory blood pressure
90 days
snoring
90 days
Study Arms (3)
Positive airway pressure (PAP)
OTHERwhich is air delivered by a mask worn over the nose during sleep
outpatient surgical procedure
ACTIVE COMPARATORwhere small fabric rods are inserted into the soft palate (the fleshy portion of the roof of the mouth) to stiffen the tissues.
Sham surgery
SHAM COMPARATORan outpatient surgical procedure identical to #2 except that no rods are inserted into the soft palate.
Interventions
which is air delivered by a mask worn over the nose during sleep
Eligibility Criteria
You may qualify if:
- Age \>18 yrs
- AHI 5-30
- Tonsil size \<50% of airway
- No anatomically fixed nasal stenosis
You may not qualify if:
- \. The presence of a concomitant untreated primary sleep disorder (restless legs syndrome, narcolepsy, idiopathic hypersomnia) 2. Severe daytime sleepiness (history of sleep-related motor vehicle or occupational accident) 3. Moderate to severe pulmonary disease (FEV1 \<50% pred) 4. Neurologic impairment (h/o CVA, TIA, neuromuscular disease, diaphragmatic paralysis) 5. Significant cardiac disease (LVEF\<50%, moderate to severe valvular disease) 6. Uncontrolled hypertension \>180/110 7. Renal disease (Scr \> 2.5) 8. Allergy to local anesthetics used for implantation procedure. 9. Pregnant or nursing women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Medtronic Xomed, Inc.collaborator
- ResMed Foundationcollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sean M. Caples, D.O.
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 7, 2005
First Posted
December 9, 2005
Study Start
December 1, 2005
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
May 20, 2011
Record last verified: 2011-05