NCT01831258

Brief Summary

Conceptually, awareness of pressure occurs only during wakefulness. Thus reducing the pressure during wakefulness may improve therapy comfort and potentially adherence without compromizing therapy efficacy. SensAwake™ is a unique pressure relief technology developed by Fisher \& Paykel Healthcare which detects irregularity in the flow signal indicative of the transition from sleep to wake. When the transition from sleep to wake is detected the device promptly reduces the pressure to help facilitate a return to sleep. The purpose of this study is to compare adherence and sleep quality outcomes in patients treated by CPAP with and without SensAwake technology. It is hypothesised that participants with SensAwake on will have improved adherence and sleep quality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

3 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

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 15, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
2.9 years until next milestone

Results Posted

Study results publicly available

July 19, 2017

Completed
Last Updated

July 19, 2017

Status Verified

June 1, 2017

Enrollment Period

1.5 years

First QC Date

April 2, 2013

Results QC Date

May 25, 2017

Last Update Submit

June 20, 2017

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Adherence to CPAP Treatment

    Average used minutes (all days) taken from the CPAP device.

    2 weeks

Secondary Outcomes (6)

  • Daytime Sleepiness (Subjective Sleep Quality)

    4 weeks

  • Insomnia Severity Index (Subjective Sleep Quality)

    4 weeks

  • OSA Impact of Daily Life

    4 weeks

  • OSA Impact of Daily Life (Fatigue)

    4 weeks

  • Subjective Treatment Efficacy - Patient Global Impression of Change (PGI) - Severity

    4 weeks

  • +1 more secondary outcomes

Other Outcomes (2)

  • Leak

    One night

  • Apnea Hypopnea Index (AHI)

    2 weeks

Study Arms (2)

SensAwake On

EXPERIMENTAL

The comfort feature 'SensAwake' will be turned on

Device: SensAwake On

SensAwake Off

ACTIVE COMPARATOR

The comfort feature 'SensAwake' will be turned off

Device: SensAwake Off

Interventions

SensAwake OnDEVICE
SensAwake On
SensAwake OffDEVICE
SensAwake Off

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-75 years with moderate-to-severe OSA (AHI equal to or greater than 10 per hour).
  • Successful in-lab titration polysomnography (PSG)
  • General (at home) sleep habits of:
  • At least 7 hours in bed on most nights
  • Lights out at 12 midnight or earlier
  • Fluency in both written and spoken English.

You may not qualify if:

  • Participants prescribed and fitted with any PAP device in the past 2 years
  • Contraindicated for CPAP or AutoCPAP therapy.
  • Any known factor or disease that might interfere with treatment adherence, study conduct or interpretation of the results such as severe psychiatric disease, history of non adherence to medical regimens, or unwillingness to comply with study requirements as determined by the principal investigator.
  • Other significant sleep disorder(s) that would interfere with their ability to wear CPAP as determined by the principal investigator.
  • Patients who are prescribed hypnotics and sedating medications.
  • Any surgery of the mouth, nose, sinuses or airways (for OSA, snoring or otherwise) in the past 12 months.
  • If participants are required, by the nature of their employment, to comply with therapy. For example truck drivers or airline pilots.
  • If the physician objects to their patient taking part in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Pulmonary Associates

Glendale, Arizona, 85306, United States

Location

SleepMed of Central Georgia

Macon, Georgia, United States

Location

Sleep Med of South Carolina

Columbia, South Carolina, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Dr Richard Bogan
Organization
SleepMed of South Carolina
rbogan@sleepmedinc.com
8777537633

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2013

First Posted

April 15, 2013

Study Start

March 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

July 19, 2017

Results First Posted

July 19, 2017

Record last verified: 2017-06

Locations

US(3)