Sleep Apnea, ObstructivePhase 1TrazoDoseNCT02945644
Trazodone Dose Tolerance and APAP Adherence
A Phase 1 study testing Trazodone in people with Sleep Apnea, Obstructive, run by Louis Stokes VA Medical Center at 1 site in United States.
Trial summary
Trazodone may help obstructive sleep apnea patients to stick to their therapy, but optimal dosing is unknown. This study looks at what dose of trazodone has the best balance of potential benefits to side-effects in people with obstructive sleep apnea who are either starting on positive airway pressure therapy or not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Trazodone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2017to Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Louis Stokes Cleveland VA Sleep Medicine clinic patient
- AHI greater than or equal to 5
- obstructive sleep apnea
- new initiation or nonadherence to APAP
Who cannot join
- schizophrenia
- bipolar disorder
- current use of trazodone or sedative hypnotics
- allergy to trazodone
- current use of tricyclic antidepressants or monoamine oxidase inhibitors
- current alcohol or drug abuse
Show all 14Show fewer
- heart failure
- heart attack in past 3 months
- congenital long QT, ventricular arrhythmia (including Torsades de Pointes), bradycardia, or digoxin therapy
- use of amiodarone, sotalol, dofetilide, or dronedarone
- epilepsy
- liver disease
- pregnancy (or planning pregnancy)
- right of priapism: history of priapism, sickle cell disease, Farby disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, 44106
About this study
Official title: Randomized Controlled Trial of Trazodone Dose Tolerance and APAP Adherence
Trazodone may help obstructive sleep apnea patients to stick to their therapy, but optimal dosing is unknown. This study looks at what dose of trazodone has the best balance of potential benefits to side-effects in people with obstructive sleep apnea who are either starting on positive airway pressure therapy or not adherent to it. Participants will be randomly assigned to one of three groups: trazodone 50 mg, trazodone 100 mg, or placebo for 14 days. The investigators will monitor side-effects and adherence to positive airway pressure therapy.
Read the detailed description
Clinical Significance: Trazodone is an often-used medication in clinical sleep medicine. However, there is a dearth of information on side-effects with doses typically used for sleep. In addition, a significant proportion of the VA population have obstructive sleep apnea for which the primary treatment is positive airway therapy. However, many patients have difficulty adhering to this treatment long-term. Increased adherence to this modality has been shown to improve risk for cardiovascular and neurologic co-morbidity associated with obstructive sleep apnea. This project explores both the tolerability and safety of common doses of trazodone used in clinical sleep practice as well explores potential effects on positive airway pressure therapy adherence.
Objectives: This project seeks to determine the tolerability and multi-domain effect on sleep and mood of a 14 day course of trazodone at either 50 mg or 100 mg or placebo.
Research Plan: This is a three-group, randomized, double-blind, placebo-controlled trial with prospective data collection of VA outpatient sleep clinic patients with obstructive sleep apnea with who are non-adherent or newly started on auto-titrating positive airway pressure therapy. Evaluation focuses on medication tolerability as measured by number of days before study drug discontinuation by the participant, the Treatment Satisfaction Questionnaire for Medication, the side-effect profile at the two doses (50mg and 100mg) compared to placebo as well as longitudinal collection of adherence data and standardized questionnaires on sleepiness, insomnia, depression, anxiety, and self-efficacy. The investigators also plan to longitudinally monitor coefficient of variation of breath-to-breath tidal volume, a measure of respiratory mechanics which may be affected by trazodone use. Study participants will have 2 visits at baseline and 2 weeks after randomization.
Methodology: This study will be conduced in the Louis Stokes Cleveland Medical Center - Wade Park Sleep Clinic, a tertiary institutional referral facility. Participants must be adults with obstructive sleep apnea prescribed auto-titrating positive airway therapy who are either newly initiated or do not fulfill standard criteria for adherence and do not have allergy to trazodone; current use of trazodone, monoamine oxidase inhibitors, or sedative hypnotics; alcohol or drug abuse; severe psychiatric disease; epilepsy; significant cardiac disease; liver disease; pregnancy; hypotension; or predisposition to priapism. Study staff will interview the potential participant and do a review of the medical record for exclusion criteria before consent is obtained. The investigators expect to recruit 45 participants into the study with a 20% attrition rate before completion. Hypothesis about the tolerability of trazodone and effect on positive airway therapy adherence was prespecified.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Trazodone, Placebo
- Keywords
- obstructive sleep apnea, trazodone, positive airway pressure, adherence
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrazodoneDrug
Also called oleptro, Desyrel
take at bedtime for 14 days
PlaceboDrug
take at bedtime for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | pill filled with inert material Receives: Drug: Placebo |
| Trazodone 50mg | Active comparator | Not described Receives: Drug: Trazodone |
| Trazodone 100mg | Active comparator | Not described Receives: Drug: Trazodone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discontinuation rate by participant
Did the participant discontinue trazodone at a higher rate than placebo?
Measured: 14-16 days post-randomization
Secondary outcomes (9)
3 month APAP adherence
APAP use in last 30 days (of the 3 month period) as measured by (1) average hours/day and (2) percent days with 4 or more hours use
Measured: 3 months post-randomization assessing 30 days before this 3 month period
Respiratory patterning
Variation of breath to breath tidal volume obtained from plethysmography (a stretchy band around the chest x 20 minutes while wearing APAP)
Measured: 14-16 days post-randomization
Medication Satisfaction
Treatment Satisfaction Questionnaire for Medications version II overall and subscale scores
Measured: 14-16 days post-randomization
side-effect profile
participant-reported side effects of study drug
Measured: 14-16 days post-randomization
sleepiness
Epworth Sleepiness Scale
Measured: 14-16 days post-randomization
insomnia
Insomnia Severity Index
Measured: 14-16 days post-randomization
general self-efficacy
General Self-Efficacy Scale
Measured: 14-16 days post-randomization
depression
Clinically Useful Depression Outcome Scale (CUDOS)
Measured: 14-16 days post-randomization
anxiety
Clinically Useful Anxiety Outcome Scale (CUXOS)
Measured: 14-16 days post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start13 Feb 2017
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: COVID19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louis Stokes VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Kingman Strohl, Louis Stokes VA Medical Center
- Investigators
- Kingman P Strohl, MD, Principal investigator, Louis Stokes Cleveland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945644
- Sponsor's protocol ID
- 16025-H17
- Acronym
- TrazoDose
- Status last verified
- May 2020
- First submitted
- 11 Oct 2016
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Trazodone Dose Tolerance and APAP Adherence
- ClinicalTrials.gov ID
- NCT02945644
- Acronym / sponsor ID
- TrazoDose / 16025-H17
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- obstructive sleep apnea, trazodone, positive airway pressure, adherence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: COVID19 pandemic
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Louis Stokes VA Medical CenterUS federal agency
- Study start
- 13 Feb 2017 (actual)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 26 Oct 2016 (estimated)
- 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.
Trazodone may help obstructive sleep apnea patients to stick to their therapy, but optimal dosing is unknown. This study looks at what dose of trazodone has the best balance of potential benefits to side-effects in people with obstructive sleep apnea who are either starting on positive airway pressure therapy or not adherent to it. Participants will be randomly assigned to one of three groups: trazodone 50 mg, trazodone 100 mg, or placebo for 14 days. The investigators will monitor side-effects and adherence to positive airway pressure therapy.
Detailed description
Clinical Significance: Trazodone is an often-used medication in clinical sleep medicine. However, there is a dearth of information on side-effects with doses typically used for sleep. In addition, a significant proportion of the VA population have obstructive sleep apnea for which the primary treatment is positive airway therapy. However, many patients have difficulty adhering to this treatment long-term. Increased adherence to this modality has been shown to improve risk for cardiovascular and neurologic co-morbidity associated with obstructive sleep apnea. This project explores both the tolerability and safety of common doses of trazodone used in clinical sleep practice as well explores potential effects on positive airway pressure therapy adherence.
Objectives: This project seeks to determine the tolerability and multi-domain effect on sleep and mood of a 14 day course of trazodone at either 50 mg or 100 mg or placebo.
Research Plan: This is a three-group, randomized, double-blind, placebo-controlled trial with prospective data collection of VA outpatient sleep clinic patients with obstructive sleep apnea with who are non-adherent or newly started on auto-titrating positive airway pressure therapy. Evaluation focuses on medication tolerability as measured by number of days before study drug discontinuation by the participant, the Treatment Satisfaction Questionnaire for Medication, the side-effect profile at the two doses (50mg and 100mg) compared to placebo as well as longitudinal collection of adherence data and standardized questionnaires on sleepiness, insomnia, depression, anxiety, and self-efficacy. The investigators also plan to longitudinally monitor coefficient of variation of breath-to-breath tidal volume, a measure of respiratory mechanics which may be affected by trazodone use. Study participants will have 2 visits at baseline and 2 weeks after randomization.
Methodology: This study will be conduced in the Louis Stokes Cleveland Medical Center - Wade Park Sleep Clinic, a tertiary institutional referral facility. Participants must be adults with obstructive sleep apnea prescribed auto-titrating positive airway therapy who are either newly initiated or do not fulfill standard criteria for adherence and do not have allergy to trazodone; current use of trazodone, monoamine oxidase inhibitors, or sedative hypnotics; alcohol or drug abuse; severe psychiatric disease; epilepsy; significant cardiac disease; liver disease; pregnancy; hypotension; or predisposition to priapism. Study staff will interview the potential participant and do a review of the medical record for exclusion criteria before consent is obtained. The investigators expect to recruit 45 participants into the study with a 20% attrition rate before completion. Hypothesis about the tolerability of trazodone and effect on positive airway therapy adherence was prespecified.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebopill filled with inert material |
| Trazodone 50mg | Active comparator | Drug: Trazodone |
| Trazodone 100mg | Active comparator | Drug: Trazodone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Louis Stokes Cleveland VA Sleep Medicine clinic patient
- AHI greater than or equal to 5
- obstructive sleep apnea
- new initiation or nonadherence to APAP
Key exclusion criteria (14 listed)
- schizophrenia
- bipolar disorder
- current use of trazodone or sedative hypnotics
- allergy to trazodone
- current use of tricyclic antidepressants or monoamine oxidase inhibitors
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 |
|---|---|---|
| TrazodoneAlso: oleptro, Desyreltake at bedtime for 14 days | Drug | Trazodone 100mg, Trazodone 50mg |
| Placebotake at bedtime for 14 days | Drug | Placebo |
Primary outcome
Discontinuation rate by participant
Time frame: 14-16 days post-randomization
Did the participant discontinue trazodone at a higher rate than placebo?
9 secondary outcomes
3 month APAP adherence
Time frame: 3 months post-randomization assessing 30 days before this 3 month period
Respiratory patterning
Time frame: 14-16 days post-randomization
Medication Satisfaction
Time frame: 14-16 days post-randomization
side-effect profile
Time frame: 14-16 days post-randomization
sleepiness
Time frame: 14-16 days post-randomization
insomnia
Time frame: 14-16 days post-randomization
general self-efficacy
Time frame: 14-16 days post-randomization
depression
Time frame: 14-16 days post-randomization
anxiety
Time frame: 14-16 days post-randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2020.
- 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.
Kingman P Strohl, MD principal investigator
Louis Stokes Cleveland VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trazodone in people with Sleep Apnea, Obstructive, run by Louis Stokes VA Medical Center 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 4 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: paused, as of the sponsor's last update on 11 May 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Discontinuation rate by participant (time frame: 14-16 days post-randomization). 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 11 May 2020.