SleepNCT06768970
Investigating the Effect of Daily CARDIO® Capsules Supplementation on Improved Sleep in Healthy, Urban-Dwelling Adults
A study testing CARDIO® salmon oil in people with Sleep and Pollution; Exposure, run by Hofseth Biocare ASA at 1 site in United States.
Trial summary
This study aims to explore the impact of supplementation with CARDIO® whole salmon oil capsules on healthy adult participants with sleep disruption related to particulate matter pollution. The trial will employ a decentralized approach enabled by modern technology and wearables to measure sleep quantity and quality. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Pollution; Exposure, Cough
- What is being tested?
- CARDIO® salmon oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2024to 5 Jan 2025
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age
- Participants must be between 18 and 70 years of age.
- Technological access
- Must possess the ability to access and operate a mobile or web-based device manufactured after 2008.
- Sleep disturbed by coughing resulting in daytime tiredness
- Level of cough burden over previous 24 hours self-scored at ≥40mm on the 0mm ("no cough problems") to 100mm ("most troublesome cough") cough level on visual analog scale (VAS) at screening and baseline
- Wearable Technology
- Ownership of a wearable device that collects and records time spent in different sleep stages (e.g., REM, Deep, Light, Awake), such as an Apple Watch, Whoop, Google Fit, Fitbit, Garmin, or Oura ring device.
Who cannot join
- Medication Restrictions:
- Use of neuromodulatory therapy (latter including gabapentin, pregabalin, morphine and amitriptyline).
- Current use of ACE (angiotensin converting enzyme) inhibitors or have taken an ACE inhibitor within 3 months of screening.
- Pregnant or lactating women
- Smoking Status:
- ● Individuals who are smokers or have smoked within the past 12 months.
Show all 17Show fewer
- Sleep Aid Limitations:
- ● Use of prescription or over-the-counter sleep aids, including both wellness and prescribed medications.
- Sleep Disorder Diagnosis:
- The presence of diagnosed sleep disorders. Alcohol
- Alcohol abuse (4 drinks per day for women and more than 12 per week and 5 or more per day for men or more than 15 drinks per week) or substance use disorder.
- Supplement Constraints:
- ● Use of fish oil, other marine oils (including algal or krill) and omega supplements is not allowed for the duration of the study, with a prerequisite of abstaining from these supplements for at least 3 months prior to participation.
- Allergic to fish Epworth Sleepiness Scale score of ≥16
- Any participant with a score of ≥16 will be advised to seek medical attention before entering the study to ensure that they have no undiagnosed medical conditions. If they are deemed medically fit and well they will be able to continue in the study.
- Lifestyle Considerations No change in dietary habits, caffeine or alcohol intake or activities of daily living.
- No shift work involving night shifts No change in use of vitamins and minerals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Decentralized Clinical Trial to Investigate the Effect of Daily Cardio Capsules (US FDA NDI) Supplementation on Improved Sleep in Healthy, Urban-Dwelling Adult Participants
This study aims to explore the impact of supplementation with CARDIO® whole salmon oil capsules on healthy adult participants with sleep disruption related to particulate matter pollution. The trial will employ a decentralized approach enabled by modern technology and wearables to measure sleep quantity and quality. Validated patient reported outcome (PRO) measures will be employed to measure the impact on cough and the subjective assessment of sleep quality and wellbeing. After a two week run-in period, subjects will be randomized to OmeGo at either 2g or 4g daily for 8 weeks. Final assessment will be at week 10.
Read the detailed description
This study aims to explore the impact of a nutritional supplement, CARDIO® salmon oil, on sleep quality and cough among adults residing in urban areas with air quality index / AQI 50 or higher. The trial will employ a decentralized approach enabled by modern technology and wearables. The co-primary endpoint is sleep quality, as measured by wearable device, and impact on cough measured via patient reported outcomes (visual analogue scale / VAS). Secondary endpoints will measure subjective change in sleep via participant-reported VAS and voluntary nasal swabs will be taken in up to 40 participants to assess change in gene expression of relevant cytokines and chemokines. Due to the exploratory nature of this study a placebo arm is not being employed, rather participants will be randomized to CARDIO® at either 2g or 4g daily for 8 weeks following a two-week run-in period where baseline sleep metrics will be recorded by wearable device and the Epworth Sleepiness Scale to measure daytime sleepiness. Final assessment will be undertaken in week 10.
- Conditions
- Sleep, Pollution; Exposure, Cough
- Being tested
- CARDIO® salmon oil
- Keywords
- salmon oil, sleep quality, environmental pollution, decentralized, virtual platform, clinical trial
- Medical subject headings
- Cough, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CARDIO® salmon oilDietary supplement
Also called OmeGo
CARDIO® is a natural salmon oil manufactured from the enzymatic hydrolysis of Norwegian Atlantic salmon. Salmon capsules contain a full spectrum omega- and non-omega marine fatty acids with naturally occurring astaxanthin.
| Study group | Role | What they receive |
|---|---|---|
| CARDIO® Capsules (2.0 g) | Experimental | The study intervention entails CARDIO® salmon oil supplementation, a nutritional product containing a full spectrum of omega fatty acids. Participants allocated to the 2g/d arm will receive two capsules daily as their dosage regimen. Receives: Dietary Supplement: CARDIO® salmon oil |
| CARDIO® Capsules (4.0 g) | Experimental | The study intervention entails CARDIO® salmon oil supplementation, a nutritional product containing a full spectrum of omega fatty acids. Participants allocated to the 4g/d arm will receive four capsules daily as their dosage regimen. Receives: Dietary Supplement: CARDIO® salmon oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of OmeGo capsules on sleep quantity and quality
Change in sleep quantity and quality to be measured via change in total sleep time (TST) and waking after sleep onset (WASO) via the use of wearables.
Measured: Baseline to week 10.
The impact of CARDIO capsules on cough symptoms from baseline to end of study
VAS score will be used to assess cough over the preceding 24 hours, measured each morning, on a 100mm scale. The VAS is easy and simple to complete and has been shown to be highly responsive to change in cough symptoms
Measured: Baseline to week 10
Secondary outcomes (2)
Subjective Sleep Quality
Subjective assessment of sleep quality via 100mm VAS with 0mm representing the "best possible sleep" and 100mm representing the "worst possible sleep".
Measured: Baseline to 8 weeks
Pro- and Anti-Inflammatory Gene Expression
Change in gene expression of inflammatory and anti-inflammatory genes (CSF2, CXCL8, IL10, TNF, IL6, IL4, IL5, TGFB1, IL13, BMP2, CRP) encoding cytokines and chemokines will be assessed using nasal swab specimens. Quantitative real-time PCR (qRT-PCR) with TaqMan probe technology will be utilized to measure gene expression levels. This analysis is voluntary and will be conducted in up to 40 subjects.
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start14 May 2024
- Primary completion15 Nov 2024
- Study completion5 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hofseth Biocare ASA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768970
- Sponsor's protocol ID
- OmeGo-Sleep-001
- Status last verified
- Jan 2025
- First submitted
- 1 Mar 2024
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Decentralized Clinical Trial to Investigate the Effect of Daily Cardio Capsules (US FDA NDI) Supplementation on Improved Sleep in Healthy, Urban-Dwelling Adult Participants
- ClinicalTrials.gov ID
- NCT06768970
- Acronym / sponsor ID
- OmeGo-Sleep-001
- Conditions
- Sleep, Pollution; Exposure, Cough
- Keywords
- salmon oil, sleep quality, environmental pollution, decentralized, virtual platform, clinical trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Hofseth Biocare ASAIndustry (pharma, biotech, devices)
- Study start
- 14 May 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 5 Jan 2025 (actual)
- First posted
- 10 Jan 2025 (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.
This study aims to explore the impact of supplementation with CARDIO® whole salmon oil capsules on healthy adult participants with sleep disruption related to particulate matter pollution. The trial will employ a decentralized approach enabled by modern technology and wearables to measure sleep quantity and quality. Validated patient reported outcome (PRO) measures will be employed to measure the impact on cough and the subjective assessment of sleep quality and wellbeing. After a two week run-in period, subjects will be randomized to OmeGo at either 2g or 4g daily for 8 weeks. Final assessment will be at week 10.
Detailed description
This study aims to explore the impact of a nutritional supplement, CARDIO® salmon oil, on sleep quality and cough among adults residing in urban areas with air quality index / AQI 50 or higher. The trial will employ a decentralized approach enabled by modern technology and wearables. The co-primary endpoint is sleep quality, as measured by wearable device, and impact on cough measured via patient reported outcomes (visual analogue scale / VAS). Secondary endpoints will measure subjective change in sleep via participant-reported VAS and voluntary nasal swabs will be taken in up to 40 participants to assess change in gene expression of relevant cytokines and chemokines. Due to the exploratory nature of this study a placebo arm is not being employed, rather participants will be randomized to CARDIO® at either 2g or 4g daily for 8 weeks following a two-week run-in period where baseline sleep metrics will be recorded by wearable device and the Epworth Sleepiness Scale to measure daytime sleepiness. Final assessment will be undertaken in week 10.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CARDIO® Capsules (2.0 g) | Experimental | Dietary Supplement: CARDIO® salmon oilThe study intervention entails CARDIO® salmon oil supplementation, a nutritional product containing a full spectrum of omega fatty acids. Participants allocated to the 2g/d arm will receive two capsules daily as their dosage regimen. |
| CARDIO® Capsules (4.0 g) | Experimental | Dietary Supplement: CARDIO® salmon oilThe study intervention entails CARDIO® salmon oil supplementation, a nutritional product containing a full spectrum of omega fatty acids. Participants allocated to the 4g/d arm will receive four capsules daily as their dosage regimen. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age
- Technological access
- Sleep disturbed by coughing resulting in daytime tiredness
- Level of cough burden over previous 24 hours self-scored at ≥40mm on the 0mm ("no cough problems") to 100mm ("most troublesome cough") cough level on visual analog scale (VAS) at screening and baseline
- Wearable Technology
Key exclusion criteria (17 listed)
- Use of neuromodulatory therapy (latter including gabapentin, pregabalin, morphine and amitriptyline).
- Current use of ACE (angiotensin converting enzyme) inhibitors or have taken an ACE inhibitor within 3 months of screening.
- Pregnant or lactating women
- ● Individuals who are smokers or have smoked within the past 12 months.
- ● Use of prescription or over-the-counter sleep aids, including both wellness and prescribed medications.
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 |
|---|---|---|
| CARDIO® salmon oilAlso: OmeGoCARDIO® is a natural salmon oil manufactured from the enzymatic hydrolysis of Norwegian Atlantic salmon. Salmon capsules contain a full spectrum omega- and non-omega marine fatty acids with naturally occurring astaxanthin. | Dietary supplement | CARDIO® Capsules (2.0 g), CARDIO® Capsules (4.0 g) |
Primary outcome
The impact of OmeGo capsules on sleep quantity and quality
Time frame: Baseline to week 10.
Change in sleep quantity and quality to be measured via change in total sleep time (TST) and waking after sleep onset (WASO) via the use of wearables.
The impact of CARDIO capsules on cough symptoms from baseline to end of study
Time frame: Baseline to week 10
VAS score will be used to assess cough over the preceding 24 hours, measured each morning, on a 100mm scale. The VAS is easy and simple to complete and has been shown to be highly responsive to change in cough symptoms
2 secondary outcomes
Subjective Sleep Quality
Time frame: Baseline to 8 weeks
Pro- and Anti-Inflammatory Gene Expression
Time frame: Baseline to 8 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 10 Jan 2025.
- Individual participant dataSharing planned: No
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Healthy Adult Participants
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 CARDIO® salmon oil in people with Sleep and Pollution; Exposure, run by Hofseth Biocare ASA 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 8 inclusion and 17 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 10 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?
The impact of OmeGo capsules on sleep quantity and quality (time frame: Baseline to week 10.). 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?
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 10 Jan 2025.