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Cognitive Behavioral Therapy for Insomnia and Obstructive Sleep Apnea

(CBT-i and UAS Trial)

TH
Overseen ByTina Harrison
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Thomas Kaffenberger
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

Obstructive sleep apnea, or OSA, affects over 1 billion adults worldwide. OSA is one of many sleep disorders. Individuals can suffer from more than one sleep disorder at a time. Insomnia (difficulty falling or staying asleep) is a separate sleep disorder that is very often seen in OSA patients. Depending on reports, insomnia can be present in 30%-60% of patients diagnosed with OSA. This research is being conducted to determine whether treating insomnia can help patients with OSA to have better outcomes when treating their OSA.

Who Is on the Research Team?

TK

Thomas Kaffenberger

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with obstructive sleep apnea who also have trouble falling or staying asleep (insomnia). Participants should be able to use upper airway stimulation therapy and follow digital insomnia treatment instructions.

Inclusion Criteria

Able to download and use the Inspire smartphone app for clinical compliance information collection
Having an internet-capable device (e.g., smartphone, tablet, or computer)
I am being treated for sleep apnea and have been diagnosed with insomnia.
See 2 more

Exclusion Criteria

Does not have access to or is unable to use an internet-capable device (smartphone, tablet, or computer)
I have done CBT-I therapy in the past 6 months.

What Are the Treatments Tested in This Trial?

Interventions

  • Digital Cognitive Behavioral Therapy (CBT-i)-COAST

Trial Overview

The study tests whether starting digital cognitive behavioral therapy for insomnia (CBT-i) at different times affects how well people stick to using their upper airway stimulation device for sleep apnea. Participants are randomly assigned when they start CBT-i.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Upfront Digital CBT-i ArmActive Control1 Intervention
Group II: Delayed Digital CBT-i ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Thomas Kaffenberger

Lead Sponsor

Inspire Medical Systems, Inc.

Industry Sponsor

Trials
14
Recruited
6,800+

Noctem, LLC

Industry Sponsor

Trials
3
Recruited
370+

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