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A randomized, double blind, placebo-controlled trial to assess the efficacy of LipZip in reducing mouth breathing on continuous positive airway pressure (CPAP) treatment.

A randomized, double-blind, placebo-controlled, crossover study to assess the efficacy of LipZip oral adhesive gel in reducing mouth breathing on continuous positive airway pressure (CPAP) treatment in patients with obstructive sleep apnea (OSA).

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000905662
Enrollment
50
Registered
2014-08-25
Start date
2014-09-29
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Continuous Positive Airway Pressure (CPAP) is the gold standard treatment for OSA. This study is aimed to assess the efficacy of LipZip in reducing mouth breathing on CPAP treatment.

Interventions

The intervention that will be used in this trial is a LipZip oral adhesive gel to reduce mouth breathing during CPAP treatment in patients with obstructive sleep apnea. LipZip is comprised of 54.7% purified water, 12% Gantrez MZ 955, 12% Kollidon 90F, 10% ethanol, 4.5% Dimethicone 200, 2% citric acid anhydrous, 2% xantham gum, 1.5% Sepigel 305, 1% aerosil 200, traces of potassium sorbate and disodium edetate. Gantrez MZ 955 possesses thickening and adhesive properties and is registered for use i

The intervention that will be used in this trial is a LipZip oral adhesive gel to reduce mouth breathing during CPAP treatment in patients with obstructive sleep apnea. LipZip is comprised of 54.7% purified water, 12% Gantrez MZ 955, 12% Kollidon 90F, 10% ethanol, 4.5% Dimethicone 200, 2% citric acid anhydrous, 2% xantham gum, 1.5% Sepigel 305, 1% aerosil 200, traces of potassium sorbate and disodium edetate. Gantrez MZ 955 possesses thickening and adhesive properties and is registered for use in oral care. Kollidon 90 F is used as a binding agent. Dimethicone is a medium silicon oil approved for personal care products. A 2mm to 3mm thick single line of LipZip gel will be applied to two-thirds of the lower lip where it comes into contact with the upper lip. It is applied once nightly prior to going to bed. Treatment adherence is assessed by self report diary and gel return. 1. Mouth breathing is a common problem during CPAP treatment. It is known to contribute to low adherence to treatment. Patients who have problems of mouthbreathing will be recruited. 2. Participants will be randomized between the active and non-active group. They will be on using the oral gel for 2 weeks for each group that they are assigned. 3. There will be a washout period of 2 weeks. 4.Participants will crossover to the next treatment group.

Sponsors

NZ Respiratory and Sleep Institute
Lead SponsorOther

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Patients diagnosed with obstructive sleep apnea with a minimum Apnea Hypopnea Index (AHI) of 15 events/hour. 2. Patients currently on CPAP treatment with known history of mouth breathing

Exclusion criteria

1. Patients on auto-adjusting PAP machine. 2. Patients with retrognathia.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026