Effectiveness of Chilipad in Enhancing Sleep Quality & Wellbeing

NCT ID: NCT06614530

Last Updated: 2024-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-01

Study Completion Date

2025-10-01

Brief Summary

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This study tests the Chilipad Dock Pro Bed Cooling System and Sleep Tracker, focusing on how temperature affects sleep quality and well-being. Over a 35-day period, metrics captured by our Sleep Tracker and participant feedback will be used to evaluate sleep quality and assess well-being. Participation requires minimal time and effort - set-up, sleep, and check-in periodically to provide feedback.

Detailed Description

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Sleep quality is a cornerstone of well-being, yet many struggle to achieve restful nights. Emerging research suggests that temperature regulation can play a vital role in sleep quality. The Chilipad Dock Pro Bed Cooling System promises to optimize sleep by maintaining an ideal temperature. Social media buzz and user testimonials have lauded its effectiveness, but scientific validation is limited.

The Chilipad Dock Pro is an advanced sleep system designed to optimize sleep by dynamically adjusting the bed\'s surface temperature. It consists of a mesh mattress pad and a Dock Pro control unit that circulates water through the pad, allowing users to customize the temperature between 55°F and 115°F. The system offers both single and dual control, making it ideal for individual or shared use. Equipped with AI-driven features, the Dock Pro can monitor sleep patterns and environmental factors to make real-time adjustments, ensuring optimal sleep conditions throughout the night. This intelligent temperature management system is enhanced when paired with the optional Sleepme Tracker, creating a personalized sleep experience.

This single-arm trial evaluates the impact of the ChiliPad Dock Pro Bed Cooling System on sleep quality and well-being. Participants act as their control, as placebos are impractical. Participants will be asked to sequentially add Chilipad functionality throughout the trial. The study will use validated scales like the PROMIS Sleep Disturbance Scale, Well-being Survey, and SF-36 to quantify the system\'s effectiveness.

Conditions

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Sleep Wellness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chilipad Docker Pro Interventional Arm

Users will receive a Chilipad Docker Pro.

Group Type EXPERIMENTAL

Chilipad Docker Pro

Intervention Type DEVICE

The Chilipad Dock Pro is an advanced sleep system designed to optimize sleep by dynamically adjusting the bed\'s surface temperature. It consists of a mesh mattress pad and a Dock Pro control unit that circulates water through the pad, allowing users to customize the temperature between 55°F and 115°F. The system offers both single and dual control, making it ideal for individual or shared use. Equipped with AI-driven features, the Dock Pro can monitor sleep patterns and environmental factors to make real-time adjustments, ensuring optimal sleep conditions throughout the night. This intelligent temperature management system is enhanced when paired with the optional Sleepme Tracker, creating a personalized sleep experience.

Interventions

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Chilipad Docker Pro

The Chilipad Dock Pro is an advanced sleep system designed to optimize sleep by dynamically adjusting the bed\'s surface temperature. It consists of a mesh mattress pad and a Dock Pro control unit that circulates water through the pad, allowing users to customize the temperature between 55°F and 115°F. The system offers both single and dual control, making it ideal for individual or shared use. Equipped with AI-driven features, the Dock Pro can monitor sleep patterns and environmental factors to make real-time adjustments, ensuring optimal sleep conditions throughout the night. This intelligent temperature management system is enhanced when paired with the optional Sleepme Tracker, creating a personalized sleep experience.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* in the United States
* recent purchaser or customer of Sleep.me

Exclusion Criteria

* Individuals with severe insomnia
* Individuals with severe allergies or skin conditions
* Individuals with pacemakers or implanted medical devices
* Individuals with severe anxiety or stress disorders
* Pregnant individuals
* Individuals who travel across timezones frequently and/or sleep in their own bed less than 21 days in a month.
* Individuals with incontinence issues
* Individuals with severe mobility issues.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Efforia, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew M Amsden, MBA

Role: PRINCIPAL_INVESTIGATOR

Efforia, Inc

Central Contacts

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Matthew M Amsden, MBA

Role: CONTACT

646-679-2479 ext. (646) 679-2479

Other Identifiers

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13223

Identifier Type: -

Identifier Source: org_study_id

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