Insomnia, PrimaryNCT03109210

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

A study testing Online Cognitive Behavioral Therapy (OCBT) and Therapist-directed Cognitive Behavioral Therapy (TCBT) in people with Insomnia, Primary and Sleep Apnea, Obstructive, run by National Jewish Health at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 21 years and older
Conditions the study is for: Insomnia, Primary, Sleep Apnea, Obstructive
What is being tested?: Online Cognitive Behavioral Therapy (OCBT) and Therapist-directed Cognitive Behavioral Therapy (TCBT)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 384 participants
Where: 2 sitesUnited States
Study dates: 15 Apr 2017to 30 Jun 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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);

Show all 12Show fewer

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

National Jewish Health
Denver, Colorado, 80206
Stanford Univeristy
Palo Alto, California, 94304

Other trials in United States

About this study

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.

Read the 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.

Conditions: Insomnia, Primary, Sleep Apnea, Obstructive
Being tested: Online Cognitive Behavioral Therapy (OCBT), Therapist-directed Cognitive Behavioral Therapy (TCBT)
Medical subject headings: Sleep Initiation and Maintenance Disorders, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Online Cognitive Behavioral Therapy (OCBT)Behavioural
Also called OCBT
Cognitive behavioral therapy delivered via commercial online software.
Therapist-directed Cognitive Behavioral Therapy (TCBT)Behavioural
Also called TCBT
Cognitive Behavioral Therapy delivered via traditional, in-person interaction with a licensed mental health professional.

Study groups in NCT03109210
Study group	Role	What they receive
Standard Care	No 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.
Intervention	Experimental	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). Receives: Behavioral: Online Cognitive Behavioral Therapy (OCBT); Behavioral: Therapist-directed Cognitive Behavioral Therapy (TCBT)

What is being measured

The primary outcome is the main question the study is designed to answer.

Insomnia Severity Index (ISI) score change
Change in participants' score on the ISI will be measured over baseline, post-treatment, and follow-up visits.
Measured: Symptom remission will be measured at post-treatment visits one and two, approximately 18 and 28 weeks following enrollment.
Quebec Sleep Questionnaire (QSQ) score change
Change in participants' score on the QSQ will be measured over baseline, post-treatment, and follow-up visits.
Measured: Participants will be asked to complete the QSQ at baseline, post-treatment, and follow-up visits, at approximately weeks 1, 18, and 28.

Secondary outcomes (3)

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.
Measured: 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.
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.
Measured: 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.
Positive Airway Pressure (PAP) Therapy Adherence
Participants' adherence to PAP therapy will be passively monitored during their participation in the study.
Measured: Adherence data will be collected through study completion, an average of one year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Apr 201730 Jun 2026

First posted12 Apr 2017
Study start15 Apr 2017
Primary completion14 Apr 2022
Study completion30 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Insomnia, PrimaryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 384 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03109210
Sponsor's protocol ID: HS2989
Status last verified: Feb 2025
First submitted: 27 Mar 2017
Last updated: 21 Feb 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 36153634

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Therapist-Directed VS Online Therapy for Insomnia Co-Occuring With Sleep Apnea
ClinicalTrials.gov ID: NCT03109210
Acronym / sponsor ID: HS2989
Conditions: Insomnia, Primary, Sleep Apnea, Obstructive
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 384 participants (estimated)
Lead sponsor: National Jewish HealthUniversity, hospital or other
Collaborators: Stanford University
Study start: 15 Apr 2017 (actual)
Primary completion: 14 Apr 2022 (actual)
Study completion: 30 Jun 2026 (estimated)
First posted: 12 Apr 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Standard Care	No 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.
Intervention	Experimental	Behavioral: Online Cognitive Behavioral Therapy (OCBT), Behavioral: Therapist-directed Cognitive Behavioral Therapy (TCBT)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).

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (12 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Online Cognitive Behavioral Therapy (OCBT)Also: OCBTCognitive behavioral therapy delivered via commercial online software.	Behavioural	Intervention
Therapist-directed Cognitive Behavioral Therapy (TCBT)Also: TCBTCognitive Behavioral Therapy delivered via traditional, in-person interaction with a licensed mental health professional.	Behavioural	Intervention

Primary outcome

Insomnia Severity Index (ISI) score change
Time frame: Symptom remission will be measured at post-treatment visits one and two, approximately 18 and 28 weeks following enrollment.
Change in participants' score on the ISI will be measured over baseline, post-treatment, and follow-up visits.
Quebec Sleep Questionnaire (QSQ) score change
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.
Change in participants' score on the QSQ will be measured over baseline, post-treatment, and follow-up visits.

3 secondary outcomes

Change in subjective measurement 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.
Change in subjective measurement of sleep efficiency
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.
Positive Airway Pressure (PAP) Therapy Adherence
Time frame: Adherence data will be collected through study completion, an average of one year.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2025.
Derived from this study: PubMed 36153634Eldridge-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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insomnia Severity Index (ISI) score change (time frame: Symptom remission will be measured at post-treatment visits one and two, approximately 18 and 28 weeks following enrollment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03109210, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2025.