InsomniaNCT06021795
Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia
A study testing Sound Treatment in people with Insomnia, run by Third Wave Therapeutics at 1 site in United States.
Trial summary
Assess the effect of a customized audio track delivered via standard commercially-available bone conduction headsets on the quality of sleep Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia
- What is being tested?
- Sound Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 31 Dec 2023
- Phase
- Interventional
- 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
- 18 years of age and older
- Meets DSM 5 criteria for insomnia disorder
- Insomnia Severity Index (ISI) of 15 - 28
Who cannot join
- Use of sleep medications, sedating or alerting medications or antidepressants in the last 3 months
- Diagnosis of any autoimmune disorder or any medical or sleep disorder that could affect sleep
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Otolaryngology Medical Group
San Francisco, California, 94108
About this study
Assess the effect of a customized audio track delivered via standard commercially-available bone conduction headsets on the quality of sleep
Read the detailed description
A single-center study in 25 subjects suffering from moderate to severe insomnia and assess the effectiveness of the intervention. Intervention consists of treatment using a customized audio track delivered via standard commercially-available bone conduction headsets daily for four (4) weeks. Effectiveness is defined by a statistically significant improvement in Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) at baseline versus the end of the study.
- Conditions
- Insomnia
- Being tested
- Sound Treatment
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sound TreatmentDevice
Customized sound audio track delivered via standard commercially available bone conduction headset
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Treatment using a customized sound audio track delivered via standard commercially available bone conduction headsets Receives: Device: Sound Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Insomnia Severity Index (ISI)
Reduction in Insomnia Severity
Measured: 4 weeks
Secondary outcomes (1)
Change in Pittsburgh Sleep Quality Index (PSQI)
Reduction in Sleep Quality
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start1 Jul 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Wave Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elan Hekier, MD, Principal investigator, San Francisco Otolaryngology Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021795
- Sponsor's protocol ID
- CP-006
- Status last verified
- Dec 2024
- First submitted
- 27 Aug 2023
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sounds for Sleep Study in Patients Suffering From Moderate to Severe Insomnia
- ClinicalTrials.gov ID
- NCT06021795
- Acronym / sponsor ID
- CP-006
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Third Wave TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 1 Sep 2023 (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.
Assess the effect of a customized audio track delivered via standard commercially-available bone conduction headsets on the quality of sleep
Detailed description
A single-center study in 25 subjects suffering from moderate to severe insomnia and assess the effectiveness of the intervention. Intervention consists of treatment using a customized audio track delivered via standard commercially-available bone conduction headsets daily for four (4) weeks. Effectiveness is defined by a statistically significant improvement in Insomnia Severity Index (ISI) and Pittsburgh Sleep Quality Index (PSQI) at baseline versus the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Sound TreatmentTreatment using a customized sound audio track delivered via standard commercially available bone conduction headsets |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age and older
- Meets DSM 5 criteria for insomnia disorder
- Insomnia Severity Index (ISI) of 15 - 28
Key exclusion criteria (3 listed)
- Use of sleep medications, sedating or alerting medications or antidepressants in the last 3 months
- Diagnosis of any autoimmune disorder or any medical or sleep disorder that could affect sleep
- Pregnancy
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 |
|---|---|---|
| Sound TreatmentCustomized sound audio track delivered via standard commercially available bone conduction headset | Device | Intervention |
Primary outcome
Change in Insomnia Severity Index (ISI)
Time frame: 4 weeks
Reduction in Insomnia Severity
1 secondary outcome
Change in Pittsburgh Sleep Quality Index (PSQI)
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2025.
- 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.
Elan Hekier, MD principal investigator
San Francisco Otolaryngology Medical Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sound Treatment in people with Insomnia, run by Third Wave Therapeutics 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 3 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 1 Jan 2025. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Insomnia Severity Index (ISI) (time frame: 4 weeks). 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 1 Jan 2025.