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Online vs Therapist-Directed Therapy for Insomnia with Sleep Apnea

N/A

Waitlist Available

Research Sponsored by National Jewish Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be > 21 years old

Participants must have a diagnosis of OSA with an AHI > 5 on a diagnostic polysomnogram

Must not have

Terminal illness (e.g., cancer), or neurological degenerative disease (e.g., dementia)

Current use of medications known to cause insomnia (e.g., stimulants)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up adherence data will be collected through study completion, an average of one year.

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare three treatments for insomnia in patients who have been diagnosed with and treated for sleep apnea: online cognitive behavioral therapy (OCBT), therapist-directed cognitive behavioral therapy (TCBT), and standard clinical care.

Who is the study for?

This trial is for adults over 21 with sleep apnea and mild insomnia, using PAP therapy for at least a month. They must have trouble sleeping despite having the chance to sleep well and feel daytime effects from poor sleep. Excluded are those with certain other sleep disorders, regular marijuana use after 4 PM, untreated major depression, recent substance abuse, or severe illnesses like cancer.

What is being tested?

The study compares three treatments: online cognitive behavioral therapy (OCBT), therapist-directed CBT (TCBT), and standard care for people with insomnia and treated sleep apnea. Participants will attend up to 15 visits including assessments, therapy sessions, and follow-ups over 10 months.

What are the potential side effects?

While not drug-related therapies that typically have side effects, participants may experience discomfort discussing personal issues or temporary increases in stress due to changes in their behavior patterns as they apply new techniques learned during therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 21 years.

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I have been diagnosed with sleep apnea and my AHI score is above 5.

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I have had trouble falling or staying asleep for over 3 months, affecting my daily life.

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I have mild or worse insomnia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a terminal illness or a neurological disease like dementia.

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I am currently taking medication that can cause sleeplessness.

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I use marijuana more than once a week or after 4:00 p.m.

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I have a sleep disorder like narcolepsy, restless legs, or my sleep schedule is very late.

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I have been diagnosed with a seizure disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ adherence data will be collected through study completion, an average of one year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~adherence data will be collected through study completion, an average of one year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and adherence data will be collected through study completion, an average of one year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insomnia Severity Index (ISI) score change

Quebec Sleep Questionnaire (QSQ) score change

Secondary study objectives

Change in subjective measurement of sleep efficiency

Change in subjective measurement of total sleep time

Positive Airway Pressure (PAP) Therapy Adherence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment2 Interventions

In addition to standard care procedures, participants randomized to the intervention arm will receive up to two sequential treatments. First, participants will receive Online Cognitive Behavioral Therapy (OCBT). Those who meet criteria for remission after this first treatment will continue through follow-up without further treatment. Those who do not will be randomized again to either extended OCBT, or Therapist-directed Cognitive Behavioral Therapy (TCBT).

Group II: Standard CareActive Control1 Intervention

Participants randomized to standard care will receive normal follow-up care with their health care provider. This will include routine assessment and adjustment of PAP therapy, and instruction in proper sleep hygiene.

0 / 9Eligibility criteria met