Clinical trial NCT06768970: Investigating the Effect of Daily CARDIO® Capsules Supplementation on Improved Sleep in Healthy, Urban-Dwelling Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Pollution; Exposure
Cough
Keywords: salmon oil
sleep quality
environmental pollution
decentralized
virtual platform
clinical trial
Lead sponsor: Hofseth Biocare ASA
Sponsor class: INDUSTRY
First posted: 2025-01-10
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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.

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

Primary outcomes:
measure: The impact of OmeGo capsules on sleep quantity and quality
timeFrame: Baseline to week 10.
measure: The impact of CARDIO capsules on cough symptoms from baseline to end of study
timeFrame: Baseline to week 10
Secondary outcomes:
measure: Subjective Sleep Quality
timeFrame: Baseline to 8 weeks
measure: Pro- and Anti-Inflammatory Gene Expression
timeFrame: Baseline to 8 weeks
Other outcomes:
measure: Correlation Between AQI and Cough Severity
timeFrame: Baseline to 8 weeks
Locations:
city: San Francisco
country: United States
facility: Alethios, Inc.
state: California
Study officials:
References: