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Completed

NCT Number: NCT04751019

The Use of Amber Glasses in Improving Sleep

The use of amber glasses will aid the patient to fall asleep without the need for the use of hypnotic medication.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Surrey and Borders NHS Foundation Trust

Leatherhead, Surrey, KT22 7AD, United Kingdom

About this study

Sleep disturbance and insomnia is extremely common and affects up to 30% of adults at any given time. Moreover, sleep disturbance is known to be particularly prevalent in patients suffering from mental illness including affective disorders, schizophrenia, anxiety (Baglioni, 2016). We hypothesise that the use of amber glasses will aid the time taken to fall asleep without the need for the use of hypnotic medication.A prospective study looking at 15 new patients admitted to one mental health ward will be undertaken. Data will be collected on twice weekly basis on the patient's use of: amber glasses alone, hypnotic medication alone or both. Hypnotic medication will include sedating antihistamines, benzodiazepines and non-benzodiazepine hypnotics such as zopiclone. Medication prescribed for dual purpose will be assumed to be used for the treatment of insomnia if given after 2300 hours. Each patient will be enrolled for a period of 4 weeks and the review of use and suitability will take place in ward review meetings.

Sleep quality will be assessed using the Pittsburgh Sleep Quality Assessment tool at baseline and at the 2 and 4 weeks. At the end of the study period, percentage use of amber glasses and zopiclone will be used to compare against a historical average of hypnotic use for the most recent 15 admissions over a similar 4 week period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18 years
  • Male or female gender
  • Presentation of mental illness (of psychotic nature, severe depression or anxiety)
  • Able to provide informed consent

Exclusion criteria

  • Patient does not consent
  • High risk assessment of self-harm or harm to others

Treatment and study plan

Amber Glasses

Device

It is hoped that the use of amber glasses to complement the natural sleep-wake by inducing a perceived 'physiological darkness' to aid the secretion of melatonin should help sleep and reduce the use of hypnotic medication

Primary outcomes

  1. The difference in the use of hypnotic medication as compared with existing data from a similar population.

    Time frame: 4 weeks

    Sleep quality will be assessed using the Pittsburgh Sleep Quality Assessment (PSQI) tool at baseline and at the 2 and 4 weeks. At the end of the study period, percentage use of amber glasses and zopiclone will be used to compare against a historical average of hypnotic use for the most recent 15 admissions over a similar 4 week period. These historic admissions will be matched for diagnosis.

Secondary outcomes

  1. Change in sleep quality as measured by a point score change in the PSQI.

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Surrey and Borders Partnership NHS Foundation Trust

Other

Registry information

Official study title

The Use of Amber Glasses in Improving Sleep and Reducing the Use of Hypnotic Medication in an Inpatient Mental Health Setting: Pilot Study

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 11, 2021
Registry last updated
Feb 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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