NCT01683721

Brief Summary

The objective of the Study is to observe the use and utility of the Winx Sleep Therapy System in a clinical practice, for the treatment of patients with obstructive sleep apnea (OSA).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

2 active sites

Status
unknown

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

September 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 4, 2013

Status Verified

September 1, 2013

Enrollment Period

1.2 years

First QC Date

September 7, 2012

Last Update Submit

September 3, 2013

Conditions

Obstructive Sleep Apnea

Study Arms (1)

Winx

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with obstructive sleep apnea (OSA)

You may not qualify if:

  • Has a severe respiratory disorder, such as severe lung disease, pneumothorax, etc.
  • Has loose teeth or advanced periodontal disease.
  • Is under the age of 18.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St. Petersburg Sleep Disorders Center

St. Petersburg, Florida, 33707, United States

RECRUITING

Sleep Medicine Associates of Texas (SMAT)

Dallas, Texas, 75231, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lawrence Siegel, MD

CONTACT

650-361-9399lsiegel@apnicure.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2012

First Posted

September 12, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

September 4, 2013

Record last verified: 2013-09

Locations

US(2)