Self-Management of Continuous Positive Airway Pressure Settings

NCT03536572 | Completed Results

• 1 other identifier: IIR 16-277
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of millions of Americans. Per the Institute of Medicine new treatment adherence strategies are needed to help improve the quality of care, reduce social and economic costs, and help those with chronic conditions, including OSA, live healthier and more productive lives through better management of their conditions. Adherence with continuous positive airway pressure (PAP) therapy is disappointingly low, and new methods to increase both the use and efficacy of therapy are needed. Historically, patients have not been formally instructed to adjust their pressure settings on their PAP devices; practically, however, allowing patients to adjust their pressure settings fosters engagement, self-confidence, and control with therapy.

Conditions

Obstructive Sleep Apnea

Keywords

Sleep Apnea Syndromes; Chronic Disease; Adherence; Self-Care; Patient Outcomes

Outcome Measures

Primary Outcomes (1)

• Treatment Adherence

  Measurement of the amount of time that CPAP is used on average per night over the outcome time frame

  2 months

Study Arms (2)

Sleep Apnea Self-Management Program

ACTIVE COMPARATOR

Protocol-based sleep apnea and CPAP education and support

Behavioral: Sleep Apnea Self-Management Program

Individualized Pressure Adjustment

EXPERIMENTAL

Additional education and support that will allow them to adjust their PAP pressures

Behavioral: Sleep Apnea Self-Management Program

Interventions

Sleep Apnea Self-Management Program BEHAVIORAL

Protocol-based sleep apnea and CPAP education and support

Also known as: SASMP

Individualized Pressure Adjustment; Sleep Apnea Self-Management Program

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The investigators' intent is to recruit a study population that is representative of patients diagnosed with OSA. To this end, entry criteria are as inclusive as possible and operationalized as follows:
• confirmed diagnosis of OSA
• being newly prescribed an OSA therapy
• having chronic symptoms per screening symptom checklist
• fluency in English
• receiving medical care at VA San Diego Healthcare System
• OSA diagnosis by the investigators' Pulmonary Sleep Program has been and is currently consistent with published consensus statements50 that therapy is indicated when the apnea-hypopnea index (AHI, number of apneas + hypopneas per hour of sleep) is either (1) \>30 or (2) 5-30 AND accompanied by documented OSA symptoms, including EDS, impaired cognition, mood disorders, insomnia, or documented cardiovascular diseases. Because sleep apnea is of increasing importance in women, the investigators' plan is to oversample women by 50% so that they represent 15% of the final study sample.

You may not qualify if:

• cognitive impairment sufficient to cause inability to complete the protocol (e.g., documented MMSE \< 24/30)
• low health literacy
• residence in a geographical area outside of San Diego County (which could make some necessary in-person visits difficult)
• fatal comorbidity (life expectancy \<6 months as indicated by treating physician)
• significant documented substance/chemical abuse
• other participant circumstances or characteristics that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment (i.e.,:)
• clinical needs of patient outweighs needs of research study

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Chronic Disease

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Carl J. Stepnowky, Deputy ACOS R&D
• Organization: VA San Diego Healthcare System

carl.stepnowsky@va.gov

858-642-3269

Study Officials

• Carl J Stepnowsky, Jr., PhD

  VA San Diego Healthcare System, San Diego, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 24, 2018
• Study Start: October 1, 2018
• Primary Completion: March 31, 2023
• Study Completion: April 30, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)