Honey to Improve Sleep Quality: a Feasibility Study
Condition: Poor Quality Sleep
Study type: Interventional

Summary: 
      Inadequate sleep quality and duration may result in adverse health outcomes and poorer
      quality of life. Despite the availability of behavior modification and pharmaceuticals to aid
      sleep optimization and quality approximately 50% men and women continue to experience
      difficulty falling asleep or staying asleep. Individuals with sleep disorders may find
      adherence to such interventions difficult to maintain (e.g. behavior modification) or the
      therapies may pose a risk (e.g. dependence on pharmaceuticals). A need exists for alternative
      therapeutic interventions, particularly those that are simple and cost effective.
      Observational and anecdotal data supports honey as a functional food to promote better sleep.
      As an initial step towards developing an evidence base for honey for improvement of sleep
      quality the investigators propose to conduct a preliminary open-label proof-of-principle
      study to assess the feasibility (primary outcome) and potential effectiveness (secondary
      outcome) of honey in improving sleep quality before embarking upon a full-scale pivotal
      clinical trial. The study data will confirm safety of honey use in a population of poor
      sleepers and to identify where improvements in study design are necessary in planning of a
      larger clinical trial.
    

Detailed description: 
      The feasibility study will involve an open-label, crossover study with 20 participants (Age
      18 - 55; 10 male, 10 female) in a population-based setting meeting the inclusion criteria and
      giving informed consent. As a feasibility study, the investigators did not conduct a power
      analysis and sample size is typical of other feasibility studies. To control for possible
      differences in sex, an equal number of male and female participants will be recruited.
      Participants will be recruited from clients of the Medicine Shoppe Pharmacy (Place Riel) and
      invited to participate through their interaction with the study pharmacists (Carla Guedo or
      Amber Ly) or by poster advertisement posted at the participating pharmacy or posted around
      the university and on PAWS. Prospective participants will undergo a screening to determine
      suitability for inclusion into the trial using an adaptation of the PharmaZZZ screening form
      (see attached document). Prior to the initiation of the treatment arms, consented
      participants will have baseline characteristics collected (sex, age, body weight, smoking
      status, socio-professional status). Furthermore, consented participants will complete a
      screening form (modified from the PharmaZZZ program, see attachment) and an Insomnia Severity
      Index (see attachment).

      For the intervention, participants will be instructed to limit consumption of coffee, black
      tea, alcohol, energy drinks, and other caffeinated products one week before and during the
      treatment and washout periods. The interventions are raw honey (1.5 tablespoons) or melatonin
      (5 mg sublingual tablet). To randomize sequence of treatment and participants, the
      investigators will employ a randomization table in a standard statistical textbook. Three
      days prior to the treatment intervention, participants will be asked to eat supper at
      approximately 6 pm and maintain a consistent intake of macronutrients for each supper meal. A
      nutritionist will be consulted to help plan supper meals. During this 3 day period
      participants will complete a daily sleep hygiene Log (see attachment) and morning sleep log
      (see attachment), which assesses subjective measures of sleep quality and amount. On the
      fourth day participants will continue the daily sleep hygiene log and sleep log, and evening
      meal pattern, but will take either melatonin or honey by mouth within 30 minutes of going to
      sleep for three consecutive days. At the end of the 3 day treatment period, participants will
      discontinue with the sleep logs and prescriptive meal pattern and resume usual activities
      during a 7 day washout between treatment arms. Participants also will be asked to complete a
      Leeds Sleep Evaluation Questionnaire (LSEQ) (see attachment, slightly modified from published
      questionnaire), a standardized self-reporting instrument that assesses ease of getting to
      sleep (questions 1 - 3), the quality of sleep (questions 4, 5), awakening from sleep
      (questions 6, 7), and behavior following wakefulness (questions 8 - 10) in the morning of day
      4 and day 7 of the treatment arm. LSEQ is considered a sensitive indicator of how the subject
      perceives or feels changes in sleep quality and latency. At the end of the washout,
      participants will repeat the cycle with the alternative treatment (i.e. 3 days prior to the
      treatment intervention, participants will be asked to eat supper at 6 pm, maintain a
      consistent intake of macronutrients for each supper meal, complete a daily sleep hygiene log
      and sleep log, begin alternative treatment on fourth day for 3 days, and then discontinue
      with the sleep logs and prescriptive meal pattern, complete LSEQs, and resume usual
      activities). The investigators will provide participants with a visual schedule (calendar) to
      follow to ensure that each understands the requirements of the study.

      The honey will be Canada #2 White Honey from SweetHeart Pollinators (Janeil Enterprises,
      Eatonia, SK). Melatonin (5 mg sublingual tablet; McKesson) will be dispensed by the
      participating pharmacists (Carla Guedo or Amber Ly). Each treatment requires that the
      dispensing pharmacist place an appropriate volume of the treatments into individual
      disposable condiment containers with lids using aseptic techniques. An individual
      appropriately labeled container for each treatment day will be made available to the
      participants. The treatments will be known to the participant and study personnel. All used
      and unused containers will be returned to the pharmacist to assess compliance. The pharmacist
      will maintain accurate records of all treatments dispensed with identification of the
      participant to whom they were dispensed, date of dispensing, and unused treatments. Each
      participant will obtain the study's supply of each treatment (3 containers/treatment) in
      larger plastic bags labelled as "Study Treatment honey or melatonin" with dosing instructions
      (e.g. using a teaspoon consume the entire contents of the container once daily within 30
      minutes of going to sleep and follow with a small glass of water). The participant will
      return to the pharmacy all used and unused containers as well as completed logs and
      questionnaires to the pharmacy at the end of the study period.

      For evaluation of sleep quality, criteria will be the monitoring of participant perception of
      sleep quality by using the morning sleep logs and the LSEQ. Stopping rules or discontinuation
      criteria for a participant includes violation of exclusion criteria and non-compliance with
      the protocol. Participants will also be free to voluntarily withdraw from the study at any
      time. If a participant withdraws, no further data will be collected from the participant. The
      subjective variables of sleep quality will be assessed using repeated measures analysis of
      variance (ANOVA). Other variables of interest will be analyzed using a student's t-test for
      continuous variables and Fisher's exact test for categorical variables. Patient demographic
      data and subjective sleep variables will be reported descriptively as means and standard
      deviations.
    

Intervention name(s): Melatonin; Honey
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Melatonin (5 mg sublingual tablet) administered for 3 days; Raw Honey (1.5 tablespoons) administered for 3 days
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment