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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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Insomnia Severity Index (ISI) score change

Quebec Sleep Questionnaire (QSQ) score change

Secondary outcome measures

Change in subjective measurement of sleep efficiency

Change in subjective measurement of total sleep time

Positive Airway Pressure (PAP) Therapy Adherence

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityOTHER

2,387 Previous Clinical Trials

17,333,666 Total Patients Enrolled

National Jewish HealthLead Sponsor

140 Previous Clinical Trials

315,852 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently undertaking this clinical experiment?

"Confirmed. Clinicaltrials.gov provides evidence that this trial is actively searching for patients, having been created on April 15th 2017 and last updated February 16th 2022. At present, 384 individuals need to be recruited from 2 different medical facilities."

Answered by AI

Are there any openings left for participants in this research trial?

"Affirmative, the research revealed on clinicaltrials.gov indicates that recruitment for this study is ongoing; having been first posted on April 15th 2017 and most recently updated February 16th 2022. The trial requires 384 participants to enroll at 2 medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Therapist-Directed VS Online Therapy for Insomnia Co-Occuring With Sleep Apnea

2017. "Therapist-Directed VS Online Therapy for Insomnia Co-Occuring With Sleep Apnea". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03109210.

All > Sleep Disorders > Insomnia