ovel Insomnia Treatment Experiment (NITE): The effectiveness of incorporating appropriate guidance for sleep wearable in users with insomnia

Not Applicable

Completed

• Conditions: Insomnia; Sleep Disturbance; Mental Health - Other mental health disorders; Neurological - Other neurological disorders

• Registration Number: ACTRN12619001636145
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-25
• Study Completion: 2021-11-13
• Last Update Posted: 13 December 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

(a)18 years old or above;
(b)Able to communicate in English;
(c)Have regular access to internet, smartphone and email;
(d)Experiencing insomnia symptoms (Insomnia Severity Index of 10 or above).

Exclusion Criteria

(a)Participants who endorse symptoms of, or are known to have any of the following sleep disorders as determined by the DUKE Structured Interview for Sleep Disorders (DSISD):
oSleep apnea: loud snoring, or observed gasping or pauses in breathing, or previously diagnosed with apnea hypopnea index > 15 but not/inadequately treated;
oPreviously diagnosed Periodic Limb Movement Disorder with arousal index > 15;
oRestless Legs Syndrome occurring 3 times/week, with duration of at least one month;
oCircadian Rhythm Sleep-Wake Disorders. These include irregular and non-24-hour sleep-wake types, advanced (if habitual bedtime is earlier than 8pm and habitual wake time earlier than 4am, occasional deviation allowed) and delayed (if habitual bedtime later than 3am and habitual wake time later than 11am, occasional deviation allowed) sleep phase types;
(b)Participants with current fixed night shift work between midnight and 5am, or current rotating work schedules that require night shifts during the study period.
(c)Participants who are at risk determined by individuals who select either moderate or high on the suicidal ideation item on the baseline questionnaire.
(d)Participants who have used Fitbit in the month prior to participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified