Nasal Strips for Sleep Quality

Overseen By Joseph D Vondrasek, MS

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida State University

Disqualifiers: Cardiovascular, Respiratory, Neurological, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Are nasal strips safe for use in humans?

Nasal strips, such as Breathe Right, are generally safe for use in humans. In clinical trials, no significant adverse events were reported, except for one person who felt like sneezing after first using the strip. ^{1 2 3 4 5}

How do nasal strips improve sleep quality compared to other treatments?

Nasal strips are unique because they are a non-drug, non-invasive treatment that physically open the nostrils to improve airflow, which can reduce snoring and improve sleep quality without altering sleep architecture or causing significant side effects. ^{1 3 4 6 7}

What data supports the effectiveness of the treatment Nasal Strips for Sleep Quality?

Research shows that nasal strips can improve sleep quality by making it easier to breathe through the nose, reducing snoring loudness by 34%, and decreasing daytime sleepiness by 26% in people with mild snoring. ^{1 3 7 8 9}

Who Is on the Research Team?

Joseph Watso, PhD

Principal Investigator

Florida State University

Are You a Good Fit for This Trial?

This clinical trial is open to healthy individuals interested in finding out if using nasal strips during sleep can affect their sleep quality, morning blood pressure, and heart rate variability. Specific eligibility criteria are not provided.

Inclusion Criteria

BMI <30

Able to use a nasal dilator strip

I have a smartphone and agree to download EliteHRV and OMRON apps.

Exclusion Criteria

I have a diagnosed heart, lung, brain, kidney, liver, or metabolic condition.

Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes)

I cannot breathe through my nose.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment - External Nasal Dilator Strip

Participants wear an external nasal dilator strip during sleep for 7 consecutive nights and days. They measure blood pressure and heart rate variability immediately after waking and complete a sleep diary.

1 week

Daily self-monitoring

Treatment - No External Nasal Dilator Strip

Participants follow normal activity and sleep patterns without the nasal dilator strip for 7 consecutive nights and days. They measure blood pressure and heart rate variability immediately after waking and complete a sleep diary.

1 week

Daily self-monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• External Nasal Dilator Strip

Trial Overview The study is testing whether wearing an external nasal dilator strip at night influences the quality of sleep and cardiovascular health upon waking. It measures perceived restfulness as well as objective changes in blood pressure and heart rate variability.

How Is the Trial Designed?

Group I: External Nasal Dilator Strip Experimental Treatment 1 Intervention

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.

Group II: No External Nasal Dilator Strip Active Control 1 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 is already approved in United States, European Union, Canada for the following indications:

Approved in United States as External Nasal Dilator Strip for:

• Snoring
• Nasal Congestion
• Sleep Disorders

Approved in European Union as External Nasal Dilator Strip for:

• Nasal Obstruction
• Sleep Disorders
• Athletic Performance Enhancement

Approved in Canada as External Nasal Dilator Strip for:

• Snoring
• Nasal Congestion
• Sleep Disorders

Who Is Running the Clinical Trial?

Florida State University

Lead Sponsor

Trials

234

Recruited

41,100+

Published Research Related to This Trial

A systematic review of 14 studies involving 147 patients found that nasal dilators (both internal and external) did not significantly improve key obstructive sleep apnea (OSA) outcomes like the apnea-hypopnea index (AHI) or oxygen saturation levels.

However, internal nasal dilators showed a slight reduction in the apnea index (AI) by about 4.87 events per hour, suggesting a minor benefit compared to external nasal dilators, which had minimal impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal Dilators (Breathe Right Strips and NoZovent) for Snoring and OSA: A Systematic Review and Meta-Analysis. Camacho, M., Malu, OO., Kram, YA., et al.[2018]

In a 2-week study with 20 subjects who snore mildly, the use of a noninvasive external nasal dilator significantly improved breathing ease during sleep by 25.6% and reduced snoring loudness by 34%.

Participants also reported a 21.8% improvement in sleep quality and a 26% reduction in daytime sleepiness, indicating that the device effectively enhances overall sleep experience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A subjective evaluation of a nasal dilator on sleep & snoring. Scharf, MB., Brannen, DE., McDannold, M.[2022]

In a study of 70 subjects over 28 days, using a nasal dilator strip significantly improved subjective sleep quality, reduced daytime sleepiness, and enhanced breathing ease, indicating its potential effectiveness for those with chronic nasal congestion.

Objective measurements showed that the nasal dilator strip reduced nasal resistance by 39.1% during sleep, which may help decrease nocturnal awakenings, although polysomnography results were similar with and without the strip.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion. Wheatley, JR., Amis, TC., Lee, SA., et al.[2020]

In a study with 50 participants, all three nasal strips (BRNS and two prototypes) significantly improved nasal patency, with the prototypes showing greater improvements in nasal volume compared to the BRNS.

In a separate study with 82 participants assessing dermal tolerability over 7 nights, all strips were well tolerated with no signs of irritation, and the BRNS showed slightly better comfort ratings, although not statistically significant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Trials of Nasal Patency and Dermal Tolerability With External Nasal Dilators in Healthy Volunteers. Ward, J., Ciesla, R., Becker, W., et al.[2022]

In a study of 59 subjects with chronic nasal congestion and sleep difficulties, both the new asymmetric butterfly-shaped nasal dilator strip and the Breathe Right Nasal Strip (BRNS) significantly improved sleep satisfaction and nasal symptoms compared to a placebo after 2 weeks of use.

The butterfly prototype showed notable improvements in sleep satisfaction by day 14 and was effective in enhancing quality of life related to nasal symptoms, indicating its potential as a viable alternative to existing nasal strips.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial. Schenkel, EJ., Ciesla, R., Shanga, GM.[2022]

The external nasal dilator strip (ENDS) can effectively reduce nasal airflow resistance in some individuals, particularly those with higher resting nasal resistance, as shown in a study of 20 healthy adults.

The ENDS works by dilating the nasal valve and stabilizing the nasal walls, and its effects are enhanced when combined with a nasal decongestant, indicating a potential for improved nasal breathing during exercise.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nasal airflow dynamics: mechanisms and responses associated with an external nasal dilator strip. Kirkness, JP., Wheatley, JR., Amis, TC.[2022]

In a clinical trial with 30 patients, the Breathe Right nasal strip significantly reduced maximum snoring intensity, particularly during lighter sleep stages, indicating its efficacy as a noninvasive solution for habitual snoring.

The nasal strip was found to be safe, with no serious adverse events reported, and most users experienced improved sleep quality after a brief adjustment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of the external nasal dilator Breathe Right on snoring. Todorova, A., Schellenberg, R., Hofmann, HC., et al.[2022]

In a pilot study involving nine cancer patients with dyspnea, the use of external nasal dilator strips (ENDS) showed that one patient experienced significant improvement in breathing, while others reported varying degrees of relief.

Despite mixed results in dyspnea perception, the tolerability of ENDS was generally good, with seven out of nine patients choosing to continue using them, suggesting potential benefits for patients suffering from fatigue and cachexia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External nasal dilator strips (ENDS) may improve breathlessness in cancer patients. Neuenschwander, H., Molto, A., Bianchi, M.[2021]

In two randomized controlled trials involving 270 subjects with chronic nocturnal nasal congestion, Breathe Right Nasal Strips (BRNS) did not show a significant improvement in sleep quality compared to placebo strips after 14 days of use.

Both BRNS and placebo strips were well tolerated, but the lack of significant difference in sleep-related quality of life measures suggests a strong placebo effect may have influenced the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep Quality and Congestion with Breathe Right Nasal Strips: Two Randomized Controlled Trials. Noss, MJ., Ciesla, R., Shanga, G.[2020]

Citations

1. Egypt pubmed.ncbi.nlm.nih.gov

Nasal Dilators (Breathe Right Strips and NoZovent) for Snoring and OSA: A Systematic Review and Meta-Analysis. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

A subjective evaluation of a nasal dilator on sleep & snoring. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Objective and Subjective Effects of a Prototype Nasal Dilator Strip on Sleep in Subjects with Chronic Nocturnal Nasal Congestion. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Randomized Trials of Nasal Patency and Dermal Tolerability With External Nasal Dilators in Healthy Volunteers. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Effects of nasal dilator strips on subjective measures of sleep in subjects with chronic nocturnal nasal congestion: a randomized, placebo-controlled trial. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Nasal airflow dynamics: mechanisms and responses associated with an external nasal dilator strip. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Effect of the external nasal dilator Breathe Right on snoring. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

External nasal dilator strips (ENDS) may improve breathlessness in cancer patients. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Sleep Quality and Congestion with Breathe Right Nasal Strips: Two Randomized Controlled Trials. [2020]