Behavioral Optimization to Overcome Obstructive Sleep Apnea Treatment Barriers

ConditionSleep Apnea
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorVA Office of Research and Development

About this trial

Previous studies have shown that programs encouraging the use of OSA treatments can help patients use these treatments more often, but the improvement is usually modest. This trial will test if giving patients a decision-making tool when they are first diagnosed with OSA, and combining their responses from this tool into a supportive program, will improve sleep quality and help them use their treatment more regularly.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

referred for an overnight diagnostic sleep test to evaluate for sleep-disordered breathing during the study period

currently untreated for OSA (not prescribed therapy in the past year)

Disqualifiers

referral for overnight sleep test is for another reason than to diagnosis sleep-disordered breathing

unable to read printed material (e.g., magazine) in English language

unable to write

unstable medical/psychiatric illness (e.g., recent hospitalization)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Behavioral strategy program X plus Y

    Behavioral

    Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy. Tests behavioral strategy program X plus Y.

  • Behavioral strategy program X

    Behavioral

    Brief 4 session education program with sleep specialist focused on behavioral strategies for improving use of sleep apnea therapy Tests behavioral strategy X.

Treatment groups

128 Participants
are divided into 2 treatment groups
Group A: Sleep education program X + YExperimental treatment 1 intervention
Group B: Sleep education program XActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pittsburgh Sleep Quality Index (PSQI)

The PSQI total score will be used as a measurement of sleep quality. Scores range from 0 to 21. Higher scores indicate worse outcome.

Time frame
6-months after the end of the intervention/control sessions, which is approximately 8 months after randomization.

Secondary outcomes

1

Acceptance of therapy

Percentage of participants prescribed device therapy with \> 0 days of use in the 30 days prior to the 6-month follow-up timepoint.

Time frame
One week after the end of the intervention/control sessions, which is approximately 2 months after randomization.
2

Treatment adherence by machine report

Percentage of days of machine reported use \>= 4 hours in the prior 30 days.

Time frame
6-months after the end of the intervention/control sessions, which is approximately 8 months after randomization.

Other outcomes

1

Decisional Conflict Scale - 1 item

Decisional Conflict Scale "What's important" item. This item is scored as 0 (best) to 4 (worst).

Time frame
End of session 1, which is within 7 days of randomization.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: