Sleep Apnea SyndromesNCT01824472
Understanding the Sleep Apnea/Insomnia Interaction
A study testing CPAP, CBT and CC in people with Sleep Apnea Syndromes and Sleep Initiation and Maintenance Disorders, run by University of Pennsylvania at 1 site in United States.
Trial summary
Nearly half of all patients with obstructive sleep apnea have insomnia symptoms, and in some, but not all cases, these insomnia symptoms are caused by the obstructive sleep apnea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders
- What is being tested?
- CPAP, CBT and CC
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sleep Apnea
- Insomnia
- Age >18
Who cannot join
- Sedative/psychoactive drug use recently
- Other clinically significant sleep disorders
- Previous treatment for obstructive sleep apnea (OSA)
- Requires oxygen or bilevel PAP therapy
- Clinically unstable medical condition
- Recent shift work
Show all 14Show fewer
- Significant alcohol use
- Other clinically significant causes of insomnia
- Illicit drug use
- Prescription stimulants
- Safety restrictions
- Unable to treat sleep apnea with positive airway pressure therapy
- Communication barriers
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104
About this study
Official title: Understanding the Sleep Apnea/Insomnia Interaction: a CPAP/Sham-CPAP Trial
Nearly half of all patients with obstructive sleep apnea have insomnia symptoms, and in some, but not all cases, these insomnia symptoms are caused by the obstructive sleep apnea. The purpose of this study is to find out what type of insomnia symptoms are caused by obstructive sleep apnea and therefore most likely to respond to obstructive sleep apnea treatment with continuous positive airway pressure (also known as CPAP) and if additional treatment with cognitive-behavioral therapy for insomnia is beneficial.
- Being tested
- CPAP, CBT, sham CPAP, CC
- Medical subject headings
- Sleep Apnea Syndromes, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Also called Continuous positive airway pressure therapy
Treatment for sleep apnea
CBTBehavioural
Also called Cognitive-Behavioral Therapy for Insomnia
Treatment for insomnia
sham CPAPDevice
Also called Sham (placebo) continuous positive airway pressure
Placebo for sleep apnea
CCBehavioural
Also called Contact control
Placebo (sham) for insomnia
| Study group | Role | What they receive |
|---|---|---|
| CPAP+CC | Active comparator | Continuous Positive Airway Pressure (CPAP) therapy for sleep apnea and contact control (CC) (placebo/sham for cognitive-behavioral therapy for insomnia) Receives: Device: CPAP; Behavioral: CC |
| sham CPAP+CC | Sham comparator | sham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia) Receives: Device: sham CPAP; Behavioral: CC |
| CPAP+CBT | Active comparator | CPAP therapy for sleep apnea and cognitive-behavioral therapy (CBT) for insomnia Receives: Device: CPAP; Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index Score
Insomnia Severity Index. Minimum: 0. Maximum: 28. Higher scores mean worse outcome. The outcome measure is reported as a change score in which the score at baseline is subtracted from the score at follow-up, thus the more negative the score, the larger the improvement. The total score represents an addition of the questions totals; there is no specific subscale modification required to calculate the total score.
Measured: Between Baseline and Day 42.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01824472
- Sponsor's protocol ID
- 814153
- Other IDs
- R34HL109462
- Status last verified
- Jul 2020
- First submitted
- 1 Apr 2013
- Last updated
- 5 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Sleep Apnea/Insomnia Interaction: a CPAP/Sham-CPAP Trial
- ClinicalTrials.gov ID
- NCT01824472
- Acronym / sponsor ID
- 814153
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2013 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 4 Apr 2013 (estimated)
- Results
- Posted 5 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Nearly half of all patients with obstructive sleep apnea have insomnia symptoms, and in some, but not all cases, these insomnia symptoms are caused by the obstructive sleep apnea. The purpose of this study is to find out what type of insomnia symptoms are caused by obstructive sleep apnea and therefore most likely to respond to obstructive sleep apnea treatment with continuous positive airway pressure (also known as CPAP) and if additional treatment with cognitive-behavioral therapy for insomnia is beneficial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CPAP+CC | Active comparator | Device: CPAP, Behavioral: CCContinuous Positive Airway Pressure (CPAP) therapy for sleep apnea and contact control (CC) (placebo/sham for cognitive-behavioral therapy for insomnia) |
| sham CPAP+CC | Sham comparator | Device: sham CPAP, Behavioral: CCsham CPAP (ineffective CPAP--placebo/sham for sleep apnea) and contact control (placebo/sham for cognitive-behavioral therapy for insomnia) |
| CPAP+CBT | Active comparator | Device: CPAP, Behavioral: CBTCPAP therapy for sleep apnea and cognitive-behavioral therapy (CBT) for insomnia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Sleep Apnea
- Insomnia
- Age >18
Key exclusion criteria (14 listed)
- Sedative/psychoactive drug use recently
- Other clinically significant sleep disorders
- Previous treatment for obstructive sleep apnea (OSA)
- Requires oxygen or bilevel PAP therapy
- Clinically unstable medical condition
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 |
|---|---|---|
| CPAPAlso: Continuous positive airway pressure therapyTreatment for sleep apnea | Device | CPAP+CBT, CPAP+CC |
| CBTAlso: Cognitive-Behavioral Therapy for InsomniaTreatment for insomnia | Behavioural | CPAP+CBT |
| sham CPAPAlso: Sham (placebo) continuous positive airway pressurePlacebo for sleep apnea | Device | sham CPAP+CC |
| CCAlso: Contact controlPlacebo (sham) for insomnia | Behavioural | CPAP+CC, sham CPAP+CC |
Primary outcome
Insomnia Severity Index Score
Time frame: Between Baseline and Day 42.
Insomnia Severity Index. Minimum: 0. Maximum: 28. Higher scores mean worse outcome. The outcome measure is reported as a change score in which the score at baseline is subtracted from the score at follow-up, thus the more negative the score, the larger the improvement. The total score represents an addition of the questions totals; there is no specific subscale modification required to calculate the total score.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP, CBT and CC in people with Sleep Apnea Syndromes and Sleep Initiation and Maintenance Disorders, run by University of Pennsylvania at 1 site in United States.
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 3 inclusion and 14 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: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 5 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Score (time frame: Between Baseline and Day 42.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2020.