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NCT04608773 · OUTCOME

Sleeping Difficulty Due to Oral Dryness

Blinded Dry Mouth Spray Crossover Study · Source last updated 2024-02-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
units on a scale
Interval / dispersion
Standard Deviation
Time frame
2 week trial

What was measured

sleeping difficulty due to oral dryness was documented via questionnaire completion by participants administered via Qualtrics. Sleeping difficulty will be measured on a 0-100 point scale "During the last three days, due to the dryness of your mouth and tongue, how difficult was it to sleep? Consider such factors as how difficult it was for you to go to sleep, the duration and quality of your sleep, and how often you woke up to drink or urinate. Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy" (Higher score means better outcome)

Analysis population: Number of participants in analysis is less than overall number of participants due to missing responses.

Groups in this outcome

Biotene Spray

Participants who received Biotene spray either in the first or last 2 week trial period.

Refresh Spray

Participants who received Refresh spray either in the first or second 2 week trial period.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Biotene Spray96
Refresh Spray96

Reported measurements

Sleep Baseline

Analysis denominator · Participants

GroupSource count
Biotene Spray90
Refresh Spray90
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Biotene Spray56.327.0Not reportedNot reportedNot reported
Refresh Spray61.926.3Not reportedNot reportedNot reported
Sleep 2 weeks

Analysis denominator · Participants

GroupSource count
Biotene Spray96
Refresh Spray96
Values in units on a scale · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Biotene Spray66.823.0Not reportedNot reportedNot reported
Refresh Spray64.824.9Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    .109
    statistical Method
    ANCOVA
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    .109
    statistical Method
    ANCOVA
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        27.0
        value
        56.3
      2. group Id
        OG001
        spread
        26.3
        value
        61.9
    denoms
    1. counts
      1. group Id
        OG000
        value
        90
      2. group Id
        OG001
        value
        90
      units
      Participants
    title
    Sleep Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        23.0
        value
        66.8
      2. group Id
        OG001
        spread
        24.9
        value
        64.8
    denoms
    1. counts
      1. group Id
        OG000
        value
        96
      2. group Id
        OG001
        value
        96
      units
      Participants
    title
    Sleep 2 weeks
denoms
  1. counts
    1. group Id
      OG000
      value
      96
    2. group Id
      OG001
      value
      96
    units
    Participants
description
sleeping difficulty due to oral dryness was documented via questionnaire completion by participants administered via Qualtrics. Sleeping difficulty will be measured on a 0-100 point scale "During the last three days, due to the dryness of your mouth and tongue, how difficult was it to sleep? Consider such factors as how difficult it was for you to go to sleep, the duration and quality of your sleep, and how often you woke up to drink or urinate. Very Difficult 0 10 20 30 40 50 60 70 80 90 100 Easy" (Higher score means better outcome)
dispersion Type
Standard Deviation
groups
  1. description
    Participants who received Biotene spray either in the first or last 2 week trial period.
    id
    OG000
    title
    Biotene Spray
  2. description
    Participants who received Refresh spray either in the first or second 2 week trial period.
    id
    OG001
    title
    Refresh Spray
param Type
MEAN
population Description
Number of participants in analysis is less than overall number of participants due to missing responses.
reporting Status
POSTED
time Frame
2 week trial
title
Sleeping Difficulty Due to Oral Dryness
type
SECONDARY
unit Of Measure
units on a scale

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice