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

Primary Purpose

Insomnia, Primary, Sleep Apnea, Obstructive

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Online Cognitive Behavioral Therapy (OCBT)

Therapist-directed Cognitive Behavioral Therapy (TCBT)

About this trial

This is an interventional treatment trial for Insomnia, Primary

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

To be included participants must > 21 years old and:

have a diagnosis of OSA with an AHI > 5 on a diagnostic polysomnogram;
accept PAP as primary/sole OSA therapy, been given a prescription for PAP and filled it within the last 3 months, have had an opportunity to use PAP for at least one month, and show mean use of > 1 hour per night;
have a complaint of persistent (i.e., > 3 months) sleep onset or sleep maintenance difficulties despite having adequate opportunity for sleep and accompanied by significant daytime impairment or distress about poor sleep;
an Insomnia Severity Index (ISI) score > 10 indicating at least "mild" insomnia; and
a sleep onset latency or wake time after sleep onset > 30 minutes 3 or more nights per week during two weeks of sleep diary monitoring.

Exclusion Criteria:

an untreated psychiatric disorder (e.g., major depression) found on structured interviews as these conditions have specific treatments and it would be inappropriate not to offer those treatments;
a lifetime diagnosis of any psychotic or bipolar disorder as sleep restriction for insomnia may precipitate hallucinations and mania;
an imminent risk for suicide;
alcohol or drug abuse within the past year;
terminal illness (e.g., cancer), or neurological degenerative disease (e.g., dementia);
current use of medications known to cause insomnia (e.g., stimulants);
comorbid narcolepsy, idiopathic hypersomnia, restless legs syndrome (score of >11 in the IRLS), periodic limb movement during sleep (known PLMS with arousal > 15 per hour), or a circadian rhythm sleep disorder if habitual bedtimes are later than 3:00 AM or rising times are later than 11:00 AM; or
consuming > 2 alcoholic beverages per day on a regular basis; or
consuming more than 10 caffeinated beverages per day on a regular basis; or
consuming marijuana in any form on a regular basis >1 time per week, or if used after 4:00 p.m; or
change in thyroid medication dosage or received a new prescription for thyroid medication 3 months before the screening visit; or
physician-diagnosed or self-reported seizure disorder.

Sites / Locations

Stanford UniveristyRecruiting
National Jewish HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Care

Intervention

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Insomnia Severity Index (ISI) score change

Change in participants' score on the ISI will be measured over baseline, post-treatment, and follow-up visits.

Quebec Sleep Questionnaire (QSQ) score change

Change in participants' score on the QSQ will be measured over baseline, post-treatment, and follow-up visits.

Secondary Outcome Measures

Change in subjective measurement of total sleep time

Participants will be asked to fill out a sleep diary throughout the study. Study personnel will use these diaries to calculate subjective assessment of total sleep time.

Change in subjective measurement of sleep efficiency

Participants will be asked to fill out a sleep diary throughout the study. Study personnel will use these diaries to calculate subjective assessment of sleep efficiency.

Positive Airway Pressure (PAP) Therapy Adherence

Participants' adherence to PAP therapy will be passively monitored during their participation in the study.

Full Information

NCT ID

NCT03109210

First Posted

March 27, 2017

Last Updated

February 16, 2022

Sponsor

National Jewish Health

Collaborators

Stanford University

1. Study Identification

Unique Protocol Identification Number

NCT03109210

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Recruiting

Study Start Date

April 15, 2017 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

April 14, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Jewish Health

Collaborators

Stanford University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This two-site randomized clinical trial will investigate and 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. 384 patients will be recruited and will attend up to 15 visits over 10 months. Visits will include baseline assessment, treatment visits, and post-treatment follow-up visits. Visits will involve completion of questionnaires, meeting with therapists, and a physical exam.

Detailed Description

This dual-site randomized clinical trial will use a "SMART" design to test a stepped care model relative to standard positive airway pressure (PAP) therapy and determine if (1) augmentation of PAP therapy with online Cognitive Behavioral Therapy improves short-term outcomes of comorbid obstructive sleep apnea(OSA)/insomnia; and (2) providing a higher intensity 2nd-stage cognitive behavioral therapy (CBT) to patients who show sub-optimal short-term outcomes with OCBT+PAP improves short and longer-term outcomes. After completing baseline assessment, the 384 comorbid OSA\insomnia patients enrolled will be randomized to a 1st-stage therapy that includes usual care PAP + OCBT (n=288) or UC (usual care PAP + sleep hygiene education; n=96). Insomnia and OSA will be reassessed after 8 weeks. OCBT recipients who meet "remission" criteria will continue PAP but be offered no additional insomnia intervention and will complete study outcome measures again after an additional 8-weeks and at 3 and 6 month follow-ups. OCBT recipients classified as "unremitted" after 8 weeks of treatment will be re-randomized to a 2nd-stage treatment consisting of continued, expanded engagement in OCBT or a switch to therapist-directed CBT (TCBT). Those receiving the 2nd-stage intervention as well as the UC group will be reassessed after another 8 weeks and at 3- and 6-month follow-up time points.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insomnia, Primary, Sleep Apnea, Obstructive

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

384 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard Care

Arm Type

No Intervention

Arm Description

Arm Title

Intervention

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Online Cognitive Behavioral Therapy (OCBT)

Other Intervention Name(s)

OCBT

Intervention Description

Cognitive behavioral therapy delivered via commercial online software.

Intervention Type

Behavioral

Intervention Name(s)

Therapist-directed Cognitive Behavioral Therapy (TCBT)

Other Intervention Name(s)

TCBT

Intervention Description

Cognitive Behavioral Therapy delivered via traditional, in-person interaction with a licensed mental health professional.

Primary Outcome Measure Information:

Title

Insomnia Severity Index (ISI) score change

Description

Change in participants' score on the ISI will be measured over baseline, post-treatment, and follow-up visits.

Time Frame

Symptom remission will be measured at post-treatment visits one and two, approximately 18 and 28 weeks following enrollment.

Title

Quebec Sleep Questionnaire (QSQ) score change

Description

Change in participants' score on the QSQ will be measured over baseline, post-treatment, and follow-up visits.

Time Frame

Participants will be asked to complete the QSQ at baseline, post-treatment, and follow-up visits, at approximately weeks 1, 18, and 28.

Secondary Outcome Measure Information:

Title

Change in subjective measurement of total sleep time

Description

Participants will be asked to fill out a sleep diary throughout the study. Study personnel will use these diaries to calculate subjective assessment of total sleep time.

Time Frame

Participants will be asked to complete two weeks of sleep diaries at baseline (week 1), post-treatment (weeks 8 and 18), and follow-up visits (months 9 and 12) to measure change in these assessments over time.

Title

Change in subjective measurement of sleep efficiency

Description

Participants will be asked to fill out a sleep diary throughout the study. Study personnel will use these diaries to calculate subjective assessment of sleep efficiency.

Time Frame

Title

Positive Airway Pressure (PAP) Therapy Adherence

Description

Participants' adherence to PAP therapy will be passively monitored during their participation in the study.

Time Frame

Adherence data will be collected through study completion, an average of one year.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: To be included participants must > 21 years old and: have a diagnosis of OSA with an AHI > 5 on a diagnostic polysomnogram; accept PAP as primary/sole OSA therapy, been given a prescription for PAP and filled it within the last 3 months, have had an opportunity to use PAP for at least one month, and show mean use of > 1 hour per night; have a complaint of persistent (i.e., > 3 months) sleep onset or sleep maintenance difficulties despite having adequate opportunity for sleep and accompanied by significant daytime impairment or distress about poor sleep; an Insomnia Severity Index (ISI) score > 10 indicating at least "mild" insomnia; and a sleep onset latency or wake time after sleep onset > 30 minutes 3 or more nights per week during two weeks of sleep diary monitoring. Exclusion Criteria: an untreated psychiatric disorder (e.g., major depression) found on structured interviews as these conditions have specific treatments and it would be inappropriate not to offer those treatments; a lifetime diagnosis of any psychotic or bipolar disorder as sleep restriction for insomnia may precipitate hallucinations and mania; an imminent risk for suicide; alcohol or drug abuse within the past year; terminal illness (e.g., cancer), or neurological degenerative disease (e.g., dementia); current use of medications known to cause insomnia (e.g., stimulants); comorbid narcolepsy, idiopathic hypersomnia, restless legs syndrome (score of >11 in the IRLS), periodic limb movement during sleep (known PLMS with arousal > 15 per hour), or a circadian rhythm sleep disorder if habitual bedtimes are later than 3:00 AM or rising times are later than 11:00 AM; or consuming > 2 alcoholic beverages per day on a regular basis; or consuming more than 10 caffeinated beverages per day on a regular basis; or consuming marijuana in any form on a regular basis >1 time per week, or if used after 4:00 p.m; or change in thyroid medication dosage or received a new prescription for thyroid medication 3 months before the screening visit; or physician-diagnosed or self-reported seizure disorder.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Rachel Johnson, MA

Phone

303-398-1058

johnsonr@njhealth.org

Facility Information:

Facility Name

Stanford Univeristy

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bella Scott, BA

Phone

650-721-1256

bella09@stanford.edu

Facility Name

National Jewish Health

City

Denver

State/Province

Colorado

ZIP/Postal Code

80206

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bryan Simmons

Phone

303-398-1850

simmonsb@njhealth.org

First Name & Middle Initial & Last Name & Degree

Jack D Edinger, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36153634

Citation

Eldridge-Smith ED, Manber R, Tsai S, Kushida C, Simmons B, Johnson R, Horberg R, Depew A, Abraibesh A, Simpson N, Strand M, Espie CA, Edinger JD. Stepped care management of insomnia co-occurring with sleep apnea: the AIR study protocol. Trials. 2022 Sep 24;23(1):806. doi: 10.1186/s13063-022-06753-4.

Results Reference

derived

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

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