The Effects of External Nasal Dilator Strips on Sleep and Cardiovascular Health

NCT06403098 | Completed FDA Device

• 1 other identifier: STUDY00004863
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this interventional study is to learn if wearing an external nasal dilator strip while sleeping changes objective and perceived sleep quality, immediate post-waking blood pressure, and immediate-post waking heart rate variability.

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

• Weekly averaged systolic blood pressure

  Brachial systolic blood pressure will be measured with an automated blood pressure monitor (OMRON BP5250).

  Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.

• Weekly averaged diastolic blood pressure

  Brachial diastolic blood pressure will be measured with an automated blood pressure monitor (OMRON BP5250).

  Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.

• Weekly average low to high frequency heart rate variability ratio

  Heart rate variability will be measured with a Polar H10 and the Elite-HRV mobile application.

  Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.

• Weekly averaged Heart rate

  Heart rate will be measured with a Polar H10 and the Elite-HRV mobile application.

  Immediate post-waking for 14 consecutive days. Weekly averages (e.g. day 1-7 vs 8-14) will be compared between conditions.

Secondary Outcomes (2)

• Weekly averaged sleep efficiency

  During sleep for 14 consecutive days (7 per condition).

• Weekly averaged self-rated sleep quality

  Immediate post-waking for 14 consecutive days (7 per condition).

Study Arms (2)

No External Nasal Dilator Strip

NO INTERVENTION

The control arm will last 7 consecutive nights and days. Participants will be asked to follow normal activity and sleep patterns. Immediately after waking the participants will measure their blood pressure and heart rate variability and complete a sleep diary to characterize subjective sleep quality. A wrist-based activity monitor will measure objective sleep quality during the control arm.

External Nasal Dilator Strip

EXPERIMENTAL

The experimental arm will last 7 consecutive nights and days. Participants will be asked to follow normal activity and sleep patterns, but they will wear an external nasal dilator strip during sleep. Immediately after waking the participants will measure their blood pressure and heart rate variability and complete a sleep diary to characterize subjective sleep quality. A wrist-based activity monitor will measure objective sleep quality during the experimental arm.

Device: External Nasal Dilator Strip

Interventions

External Nasal Dilator Strip DEVICE

Participants will wear an extra strength Breathe Right nasal strip overnight.

External Nasal Dilator Strip

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-30
• BMI \<30
• Has a smartphone and is willing to download EliteHRV and OMRON mobile applications.
• Able to use a nasal dilator strip

You may not qualify if:

• Overt cardiovascular (e.g., diagnosed hypertension), respiratory, neurological, renal, liver, and/or metabolic health conditions.
• Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes).
• Currently pregnant, trying to become pregnant, or lactating.
• Inability to breathe through the nose.

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Cardiovascular and Applied Physiology Laboratory

Tallahassee, Florida, 32306, United States

Location

Study Officials

• Joseph Watso, PhD

  Florida State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 3, 2024
• First Posted: May 7, 2024
• Study Start: May 2, 2024
• Primary Completion: June 16, 2025
• Study Completion: June 16, 2025
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: One year after completion of the trial, indefinitely
• Access Criteria: A formal plan identifying the intended use of the data and proper completion of appropriate data and/or material transfer agreement approvals with the study PI and their institution.

Locations

US (1)