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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01454830
Other study ID # 37007
Secondary ID 4R00NR011173
Status Active, not recruiting
Phase Phase 1
First received October 12, 2011
Last updated December 29, 2013
Start date November 2011
Est. completion date February 2014

Study information

Verified date December 2013
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Description:

Poor adherence to CPAP is a significant problem among OSA patients resulting in suboptimal health and functional outcomes. Intervention studies to promote CPAP adherence have shown relatively small effects in selected samples and were costly. The overall objective of this research is to examine the effect, feasibility, and acceptability of a tailored intervention on CPAP adherence among adults with newly-diagnosed, CPAP treated OSA. The central hypothesis is that critically timed tailored interventions that focus on sociocultural aspects and cognitive perceptions of the individual experience with OSA diagnosis and treatment will improve overall CPAP adherence rates. The pilot randomized controlled trial will examine CPAP adherence outcomes at 1wk, 1mo, and 3mo among those randomly assigned to the tailored intervention or usual (standard) care and examine specific feasibility and participant acceptability outcomes in order to design and conduct a subsequent larger randomized controlled trial testing the overall efficacy of the tailored intervention.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 72
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- males and females >/= 18 years of age

- newly diagnosed with apnea/hypopnea index >/= 10 events/hr

- CPAP naive

- able to read and speak English

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Tailored
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
Other:
Usual care
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

Locations

Country Name City State
United States Penn State Hershey Medical Center Hershey Pennsylvania

Sponsors (3)

Lead Sponsor Collaborator
Milton S. Hershey Medical Center National Institute of Nursing Research (NINR), Sigma Theta Tau International

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Nightly CPAP use Mean CPAP use, hrs/night 1 week No
Primary Nightly CPAP use Mean CPAP use, hrs/night 1 month No
Primary Nightly CPAP use Mean CPAP use, hrs/night 3 months No
Secondary Proportion of sleep time on CPAP % of Total Sleep Time (TST) using CPAP 1 week No
Secondary Proportion of patients enrolled after positive screening Feasibility assessment 24 months No
Secondary Proportion of participants complete protocol Feasibility assessment 24 months No
Secondary Proportion of participants who withdrawal Feasibility assessment 24 months No
Secondary Study personnel training costs Feasibility assessment aimed at projecting budget requirements for subsequent larger trial 24 months No
Secondary Acceptability of study intervention and comparative group Feasibility assessment to determine participant acceptance of the study intervention and comparative condition (i.e., usual care); semi-structured interviews conducted with 50% of participants randomly assigned to "interview" at study debriefing (3 months) 3 months No
Secondary Proportion of sleep time using CPAP % of total sleep time (TST) using CPAP 1 month No
Secondary Proportion of sleep time using CPAP % of total sleep time (TST) using CPAP 3 months No
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