NCT01454830

Brief Summary

The purpose of this study is to examine the feasibility of a tailored (i.e., individualized) intervention to promote adherence to continuous positive airway pressure therapy (CPAP) in adults with newly-diagnosed, CPAP treated, obstructive sleep apnea.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2011

Typical duration for phase_1

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

First Submitted

Initial submission to the registry

October 12, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

November 23, 2016

Completed
Last Updated

November 23, 2016

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

October 12, 2011

Results QC Date

August 5, 2016

Last Update Submit

September 30, 2016

Conditions

Sleep Apnea, ObstructivePatient Compliance

Keywords

Social supportCognitionAdaptation, psychologicalHealth behaviorPatient education

Outcome Measures

Primary Outcomes (3)

  • Nightly CPAP Use

    Mean CPAP use, hrs/night

    1 week

  • Nightly CPAP Use

    Mean CPAP use, hrs/night

    1 month

  • Nightly CPAP Use

    Mean CPAP use, hrs/night

    3 months

Secondary Outcomes (4)

  • Proportion of Sleep Time on CPAP

    1 week

  • Proportion of Participants Who Complete Protocol After Allocation

    Duration of protocol period

  • Proportion of Participants Who Withdrawal

    Duration of protocol period

  • Acceptability of Study Intervention and Comparative Group

    3 months

Study Arms (2)

Tailored

EXPERIMENTAL

Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions

Behavioral: Tailored

Usual care

ACTIVE COMPARATOR

The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment

Other: Usual care

Interventions

TailoredBEHAVIORAL

Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy

Also known as: Individualized
Tailored
Usual careOTHER

Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care

Also known as: standard of care
Usual care

Eligibility Criteria

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

You may qualify if:

  • males and females \>/= 18 years of age
  • newly diagnosed with apnea/hypopnea index \>/= 10 events/hr
  • CPAP naive
  • able to read and speak English

You may not qualify if:

  • previous diagnosis and/or treatment of OSA
  • major new psychiatric diagnosis within 6 months of study enrollment
  • require supplemental oxygen or bilevel positive airway pressure on CPAP titration polysomnogram
  • diagnosis of co-existent sleep disorder on polysomnogram, including periodic limb movements \>/= 10 events/hr with arousal, central sleep apnea with \>/= 5 central events/hr, insomnia, sleep hypoventilation syndrome, or narcolepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Related Publications (5)

  • Sawyer AM, Deatrick JA, Kuna ST, Weaver TE. Differences in perceptions of the diagnosis and treatment of obstructive sleep apnea and continuous positive airway pressure therapy among adherers and nonadherers. Qual Health Res. 2010 Jul;20(7):873-92. doi: 10.1177/1049732310365502. Epub 2010 Mar 30.

    PMID: 20354236BACKGROUND

  • Sawyer AM, Canamucio A, Moriarty H, Weaver TE, Richards KC, Kuna ST. Do cognitive perceptions influence CPAP use? Patient Educ Couns. 2011 Oct;85(1):85-91. doi: 10.1016/j.pec.2010.10.014. Epub 2010 Nov 10.

    PMID: 21071166BACKGROUND

  • Sawyer AM, Gooneratne NS, Marcus CL, Ofer D, Richards KC, Weaver TE. A systematic review of CPAP adherence across age groups: clinical and empiric insights for developing CPAP adherence interventions. Sleep Med Rev. 2011 Dec;15(6):343-56. doi: 10.1016/j.smrv.2011.01.003. Epub 2011 Jun 8.

    PMID: 21652236BACKGROUND

  • Weaver TE, Maislin G, Dinges DF, Younger J, Cantor C, McCloskey S, Pack AI. Self-efficacy in sleep apnea: instrument development and patient perceptions of obstructive sleep apnea risk, treatment benefit, and volition to use continuous positive airway pressure. Sleep. 2003 Sep;26(6):727-32. doi: 10.1093/sleep/26.6.727.

    PMID: 14572127BACKGROUND

  • Yang H, Watach A, Varrasse M, King TS, Sawyer AM. Clinical Trial Enrollment Enrichment in Resource-Constrained Research Environments: Multivariable Apnea Prediction (MAP) Index in SCIP-PA Trial. J Clin Sleep Med. 2018 Feb 15;14(2):173-181. doi: 10.5664/jcsm.6926.

    PMID: 29246264DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructivePatient ComplianceHealth Behavior

Interventions

Precision MedicineStandard of Care

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceBehavior

Intervention Hierarchy (Ancestors)

TherapeuticsQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Limitations and Caveats

Sampling bias with convenience sampling leading to relatively few PAP users meeting definition of non-adherence (threshold definition \</= 4hrs/night PAP use); Modest intervention fidelity (i.e., delivery) for telephone-delivered exposure period

Results Point of Contact

Title
Amy M. Sawyer, PhD
Organization
The Pennsylvania State University
ams24@psu.edu
814-863-1020

Study Officials

  • Amy M Sawyer, PhD

    The Pennsylvania State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 12, 2011

First Posted

October 19, 2011

Study Start

November 1, 2011

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

November 23, 2016

Results First Posted

November 23, 2016

Record last verified: 2016-09

Locations

US(1)