Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652789
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Efficacy of Sleep Hygiene Intervention in Elderly With Insomnia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Study to Evaluate the Efficacy of a Sleep Hygiene Behavior Intervention in Elderly With Insomnia
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sleep disorders are common among elderly especially among those with mental health disorders Impaired quality of sleep in elderly can lead to worsening of mental and physical health too Due to high patient to doctor ratio in India and paucity of time in busy outpatients there is inadequate information on causes of poor sleep quality in patients and a tendency to treat poor sleep with drugs Studies on effectiveness of sleep hygiene techniques in insomnia also tend to exclude elderly Thus investigators have inadequate evidence on the applicability of such interventions in the elderly In this study it is proposed to find the efficacy of a sleep hygiene behavioural intervention on severity of insomnia in elderly with sleep disturbances
Detailed Description:
Globally the older population is increasing rapidly and between 2015 and 2050 it is expected that the proportion of the worlds population over 60 years will nearly double from 12 to 22 World Health Organization 2022Untreated insomnia and other sleep disorders can have major health consequences eg cardiovascular and metabolic disease impaired cognitive functioning and increased risk of psychiatric disorders as well as an increased risk of accidents Studies have also shown that poor sleep is associated with increased risk of falls in the elderly Poor sleep quality has been shown to be associated with decline in cognitive function impaired quality of life QOL excessive daytime sleepiness fatigue depression increased mortality economic burden and possibly early institutionalization
Insomnia is defined as difficulty initiating sleep difficulty maintaining sleep morning awakening or sleep that is chronically non-restorative or poor in quality associated with daytime impairment such as fatigue memory impairment social or vocational dysfunction or mood disturbance There are several objective and subjective assessment tools for measuring sleep disorders among which polysomnography PSG is the gold standard Considering the time-consuming nature of PSG associated expense and poor availability of it to most clinicians it is generally not routinely used in the assessment of insomnia
Studies have shown that people with insomnia engage in specific poor sleep hygiene practices which may perpetuate insomnia However studies examining the effect of sleep hygiene practices on insomnia illness severity and cognition are lacking in elderly patients Sleep hygiene techniques can serve as a relatively inexpensive lifestyle intervention in elderly patients with insomnia Sleep hygiene recommendations may be delivered using a variety of media and measures print based in person discussions telephonic conversations etc resulting in increased access In addition to being commonly used and readily available sleep hygiene education does not necessarily require the direct involvement of a clinician and therefore can be widely disseminated even to elderly persons or their caregivers who may not seek medical treatment for their sleep problems
Estimated required sample size
n1 43 n2 43 n1 n2 86
Formula used
Where σ - Pooled standard deviation d - Difference between 2 group means Z1-β - Z value for corresponding power Z1-α2 - Two-sided Z value for corresponding α 196
Description of Intervention The intervention will be conducted over 6 weeks and consist of engaging patients and caregivers in two 60-minute face to face sessions 3 weeks apart and twice weekly telephonic follow ups lasting for 20 minutes each during the 6-week period
The 2 Direct face to face sessions will focus on health education about sleep Each session will be conducted by a facilitator who has received training on the program and will be delivered in a language that the participant is most fluent in English Kannada Hindi Tamil Telugu In case the participant is unable to come to the hospital for the session the facilitator will visit the home of the patient to conduct the session After taking consent
1 st face to face session 60 mins Participants and caregivers if available will be informed about the study once again
Information will be given about lifestyles that can affect sleep positively or negatively- adequate sleep time required for health healthy and unhealthy sleep habits Proper nutrition and fluid intake exercise smoking alcohol habits and their relation to sleep will be discussed Common sleep myths will be covered briefly The consequences of poor sleep will be explained The sleep hygiene intervention will have 14 simple steps to be followed by participants- 1 Foodsnacks have to be consumed at least 2 hours before bed time 2 Avoid electronic gadget usage ie mobile phone laptop for at least 1 hour before bedtime 3 Go to bed only when feeling sleepy and not before 4 Using the bedroom only for sleep or sexual activity 5 Getting out of bed if unable to fall asleep 6 Avoid fluid intake 1 hour before bedtime 7 Avoid caffeine 4 hours before bedtime 8 Avoid AlcoholSmoking 2 hours before bedtime 9 Lights should be turned offto very dim immediately after going to bed 10 Avoid planning for next day or future activities on bed 11 Do not look at the time if the sleep is disturbed in between 12 Maintain regular sleep and wake up time with maximum of ½ hour deviation 13 Avoid noisy environment after going to bed avoid discussionarguments loud songs 14 Avoid fasting Participants will be asked to rate their confidence level of following the above steps on a scale from 1 not at all confident to 10 completely confident If the participants rating is below 7 they will be asked to discuss perceived barriers to following the steps ways to overcome them and increase their confidence level to a rating of at least 7
Participants will be provided with a booklet containing all of the information covered in the first session
2 nd face to face session The session will start with participants being asked to summarize what they have learnt from the previous face to face session as well as weekly telephone calls Participants will be asked to indicate how many of the sleep hygiene techniques they were able to successfully implement since the previous session Successes and barriers faced during the previous month will be discussed Facilitator will attempt to provide solutions for standard difficulties faced Participants will be reminded that not all recommendations may work for them They will be encouraged to view the 6week period as an opportunity to discover approaches that will work for them personally
Sleep hygiene techniques will be reiterated once again The session will also involve setting goals for the following 3 weeks based on performance during the previous month Twice a week telephone calls The participants will be followed up through telephonic conversation twice weekly with a gap of three to four days in between each call Total 10 calls over 6-week period only 1 call in the weeks where the face-to-face sessions are conducted and this call will cover the points mentioned next under first call per week Data Collection Tools A questionnaire including demographic characteristics and 6 standardized tools for assessment of sleep quality depression anxiety cognitive status quality of life loneliness and pain severity will be used to collect the data for the study
1 Socio-demographic data sheet in elderly Will include name age sex address religion education occupation income marital status presence of any co-morbidities presence of any substance use diagnosed psychiatric illness duration of illness medications the patient is on participants co-morbidities list of medications that the participant is on average number of time participant wakes up to pass urine developed by the researchers
2 Pittsburgh Sleep Quality Index PSQI The PSQI is a 19-item self-rated questionnaire It was developed by Buysse et al to measure sleep quality and disturbance over the past month It is intended to be used as a standardized sleep questionnaire in clinical settings The 19 items are grouped into 7 components Each of the sleep components is scored from 0 to 3 with 3 indicating the most dysfunction The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score referred to as global score indicating worse sleep quality
3 The Montreal Cognitive Assessment MoCA The MoCA was designed as a rapid screening instrument for assessment of cognitive impairment It assesses different cognitive domains attention and concentration executive functions memory language visuoconstructional skills conceptual thinking calculations and orientation
4 Patient Health Questionnaire 9 PHQ-9 The PHQ-9 is the nine-item depression scale of the patient health questionnaire The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV The PHQ-9 can function as a screening tool an aid in diagnosis and as a symptom tracking tool that can help track a patients overall depression severity as well as track the improvement of specific symptoms with treatment
5 Generalized Anxiety Disorder scale GAD 7 The GAD-7 represents an anxiety measure based on seven items which are scored from zero to three The whole scale score can range from 0 to 21 and cut-off scores for mild moderate and severe anxiety symptoms are 5 10 and 15 respectively
6 Short form of the revised UCLA Loneliness Scale The scale consists of 3 items with response options hardly ever or never some of the time and often Responses to the items are summed to obtain the total scale score which ranges from 3 to 9 with higher scores indicating greater levels of loneliness α 072
7 WHO Quality of Life Brief Questionnaire WHOQoL BREF It consists of 24 items to assess perception of quality of life in four domains including physical health psychological social relationships and environment and two items on overall QOL and general health A higher score indicated a better QOL
8 Visual Analogue Scale for Pain The visual analog scale VAS is a validated subjective measure for acute and chronic pain Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain
Insomnia is defined as difficulty initiating sleep difficulty maintaining sleep morning awakening or sleep that is chronically non-restorative or poor in quality associated with daytime impairment such as fatigue memory impairment social or vocational dysfunction or mood disturbance There are several objective and subjective assessment tools for measuring sleep disorders among which polysomnography PSG is the gold standard Considering the time-consuming nature of PSG associated expense and poor availability of it to most clinicians it is generally not routinely used in the assessment of insomnia
Studies have shown that people with insomnia engage in specific poor sleep hygiene practices which may perpetuate insomnia However studies examining the effect of sleep hygiene practices on insomnia illness severity and cognition are lacking in elderly patients Sleep hygiene techniques can serve as a relatively inexpensive lifestyle intervention in elderly patients with insomnia Sleep hygiene recommendations may be delivered using a variety of media and measures print based in person discussions telephonic conversations etc resulting in increased access In addition to being commonly used and readily available sleep hygiene education does not necessarily require the direct involvement of a clinician and therefore can be widely disseminated even to elderly persons or their caregivers who may not seek medical treatment for their sleep problems
Estimated required sample size
n1 43 n2 43 n1 n2 86
Formula used
Where σ - Pooled standard deviation d - Difference between 2 group means Z1-β - Z value for corresponding power Z1-α2 - Two-sided Z value for corresponding α 196
Description of Intervention The intervention will be conducted over 6 weeks and consist of engaging patients and caregivers in two 60-minute face to face sessions 3 weeks apart and twice weekly telephonic follow ups lasting for 20 minutes each during the 6-week period
The 2 Direct face to face sessions will focus on health education about sleep Each session will be conducted by a facilitator who has received training on the program and will be delivered in a language that the participant is most fluent in English Kannada Hindi Tamil Telugu In case the participant is unable to come to the hospital for the session the facilitator will visit the home of the patient to conduct the session After taking consent
1 st face to face session 60 mins Participants and caregivers if available will be informed about the study once again
Information will be given about lifestyles that can affect sleep positively or negatively- adequate sleep time required for health healthy and unhealthy sleep habits Proper nutrition and fluid intake exercise smoking alcohol habits and their relation to sleep will be discussed Common sleep myths will be covered briefly The consequences of poor sleep will be explained The sleep hygiene intervention will have 14 simple steps to be followed by participants- 1 Foodsnacks have to be consumed at least 2 hours before bed time 2 Avoid electronic gadget usage ie mobile phone laptop for at least 1 hour before bedtime 3 Go to bed only when feeling sleepy and not before 4 Using the bedroom only for sleep or sexual activity 5 Getting out of bed if unable to fall asleep 6 Avoid fluid intake 1 hour before bedtime 7 Avoid caffeine 4 hours before bedtime 8 Avoid AlcoholSmoking 2 hours before bedtime 9 Lights should be turned offto very dim immediately after going to bed 10 Avoid planning for next day or future activities on bed 11 Do not look at the time if the sleep is disturbed in between 12 Maintain regular sleep and wake up time with maximum of ½ hour deviation 13 Avoid noisy environment after going to bed avoid discussionarguments loud songs 14 Avoid fasting Participants will be asked to rate their confidence level of following the above steps on a scale from 1 not at all confident to 10 completely confident If the participants rating is below 7 they will be asked to discuss perceived barriers to following the steps ways to overcome them and increase their confidence level to a rating of at least 7
Participants will be provided with a booklet containing all of the information covered in the first session
2 nd face to face session The session will start with participants being asked to summarize what they have learnt from the previous face to face session as well as weekly telephone calls Participants will be asked to indicate how many of the sleep hygiene techniques they were able to successfully implement since the previous session Successes and barriers faced during the previous month will be discussed Facilitator will attempt to provide solutions for standard difficulties faced Participants will be reminded that not all recommendations may work for them They will be encouraged to view the 6week period as an opportunity to discover approaches that will work for them personally
Sleep hygiene techniques will be reiterated once again The session will also involve setting goals for the following 3 weeks based on performance during the previous month Twice a week telephone calls The participants will be followed up through telephonic conversation twice weekly with a gap of three to four days in between each call Total 10 calls over 6-week period only 1 call in the weeks where the face-to-face sessions are conducted and this call will cover the points mentioned next under first call per week Data Collection Tools A questionnaire including demographic characteristics and 6 standardized tools for assessment of sleep quality depression anxiety cognitive status quality of life loneliness and pain severity will be used to collect the data for the study
1 Socio-demographic data sheet in elderly Will include name age sex address religion education occupation income marital status presence of any co-morbidities presence of any substance use diagnosed psychiatric illness duration of illness medications the patient is on participants co-morbidities list of medications that the participant is on average number of time participant wakes up to pass urine developed by the researchers
2 Pittsburgh Sleep Quality Index PSQI The PSQI is a 19-item self-rated questionnaire It was developed by Buysse et al to measure sleep quality and disturbance over the past month It is intended to be used as a standardized sleep questionnaire in clinical settings The 19 items are grouped into 7 components Each of the sleep components is scored from 0 to 3 with 3 indicating the most dysfunction The sleep component scores are summed to yield a total score ranging from 0 to 21 with the higher total score referred to as global score indicating worse sleep quality
3 The Montreal Cognitive Assessment MoCA The MoCA was designed as a rapid screening instrument for assessment of cognitive impairment It assesses different cognitive domains attention and concentration executive functions memory language visuoconstructional skills conceptual thinking calculations and orientation
4 Patient Health Questionnaire 9 PHQ-9 The PHQ-9 is the nine-item depression scale of the patient health questionnaire The nine items of the PHQ-9 are based directly on the nine diagnostic criteria for major depressive disorder in the DSM-IV The PHQ-9 can function as a screening tool an aid in diagnosis and as a symptom tracking tool that can help track a patients overall depression severity as well as track the improvement of specific symptoms with treatment
5 Generalized Anxiety Disorder scale GAD 7 The GAD-7 represents an anxiety measure based on seven items which are scored from zero to three The whole scale score can range from 0 to 21 and cut-off scores for mild moderate and severe anxiety symptoms are 5 10 and 15 respectively
6 Short form of the revised UCLA Loneliness Scale The scale consists of 3 items with response options hardly ever or never some of the time and often Responses to the items are summed to obtain the total scale score which ranges from 3 to 9 with higher scores indicating greater levels of loneliness α 072
7 WHO Quality of Life Brief Questionnaire WHOQoL BREF It consists of 24 items to assess perception of quality of life in four domains including physical health psychological social relationships and environment and two items on overall QOL and general health A higher score indicated a better QOL
8 Visual Analogue Scale for Pain The visual analog scale VAS is a validated subjective measure for acute and chronic pain Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None